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Country Language
* International eng
* Germany deu

NEUROMODULATION

* Healthcare
Professionals
* Chronic
Pain
* Movement
Disorders
* Get
Support

ELEVATE CARE

ACROSS THE JOURNEY WITH
NEUROSPHERE™ DIGITAL HEALTH

CHRONIC PAIN IMPACTS ROUGHLY 2.6 MILLION PATIENTS EACH YEAR1

And only an estimated 20% of those impacted reach a neurostimulation trial.1 The
pathway to treatment has many unforeseen barriers for patients and physicians
alike that can be difficult to navigate without guidance.

Our intuitive suite of digital care offerings allows your patients to maximize
their neurostimulation journey with on-demand educational resources, real-time
patient-reported outcomes, and extended care beyond clinic walls.

Get in Touch With a Rep

NEUROSPHERE™ DIGITAL HEALTH IS BUILT ON

EDUCATING PATIENTS WHO MAY BENEFIT FROM NEUROSTIMULATION

EMPOWERING PATIENTS TO TRACK THEIR PROGRESS FROM TRIAL THROUGH IMPLANT

EXTENDING PATIENT ACCESS TO SUPPORT WITH REMOTE CARE SOLUTIONS

PATIENTS CAN BETTER NAVIGATE THEIR NEUROSTIMULATION THERAPY JOURNEY WITH
NEUROSPHERE™ DIGITAL HEALTH THROUGH:

ON-DEMAND EDUCATION & SUPPORT RESOURCES

NEUROSPHERE™ MYPATH™ APP

Patients can access on-demand education and support resources early in their
neurostimulation journey and track their progress from trial through implant to
be informed across their treatment journey.

* Therapy and procedural education videos
* Patient testimonials
* Frequently asked questions
* Resource Guides
* Daily trial videos to ensure patients know what to expect
* Track trial progress with patient-reported outcomes (pain relief, well-being,
and functional improvement)
* Post-implant patient-reported device satisfaction*
* On-demand post-implant resources and live device support from Abbott’s
Therapy Navigation Center*

REMOTE PROGRAMMING ADJUSTMENTS & PRODUCT SUPPORT

NEUROSPHERE™ VIRTUAL CLINIC

Enhance the patient experience with neurostimulation therapy through extended
access to live device support and provide a flexible solution to address ongoing
programming needs:

* Use NeuroSphere™ Virtual Clinic to make programming adjustments, hold
follow-up visits or prescribe new settings to optimize therapy in clinic or
virtually
* Allow patients to connect with their care team via personal mobile device**
anywhere a cellular or Wi-Fi‡ connection is available***

PATIENTS HAVE THE OPTION TO USE THEIR OWN PERSONAL SMARTPHONE** TO ACCESS THESE
FEATURES OR USE A SMARTPHONE PROVIDED BY ABBOTT.

GET IN TOUCH WITH A REPRESENTATIVE

Contact a representative that will assist you with questions, comments, and
requests related to neuromodulation therapies.

Contact a rep

* Some NeuroSphere™ myPath™ App features are under development and not
commercially available.
** Available on eligible Apple‡ mobile devices. See a list of personal Apple‡
mobile devices compatible with Abbott’s Patient Controller app.
*** Anywhere with a WiFi‡ or cellular connection and sufficiently charged
battery.

‡ Indicates a third party trademark, which is property of its respective owner.

1. Dahlhamer J, Lucas J, Zelaya C, et al. Prevalence of chronic pain and
high-impact chronic pain among adults — United States, 2016. MMWR Morb
Mortal Wkly Rep. 2018;67(36):1001- 1006. Published 2018 Sep 14.
doi:10.15585/mmwr.mm6736a2

IMPORTANT SAFETY INFORMATION

SPINAL COLUMN STIMULATION (SCS) SYSTEMS

INTENDED USE

This neurostimulation system is designed to deliver low-intensity electrical
impulses to nerve structures. The system is intended to be used with leads and
associated extensions that are compatible with the system.

INDICATIONS FOR USE

Abbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in
the management of chronic, intractable pain of the trunk and/or limbs, including
unilateral or bilateral pain associated with the following: failed back surgery
syndrome, nonsurgical back pain (without prior surgery and not a candidate for
back surgery), and diabetic peripheral neuropathy of the lower extremities.

CONTRAINDICATIONS

This system is contraindicated for patients who are unable to operate the system
or who have failed to receive effective pain relief during trial stimulation.

MRI SAFETY INFORMATION

For more information about MR Conditional neurostimulation components and
systems, including equipment settings, scanning procedures, and a complete
listing of conditionally approved components, refer to the MRI procedures
clinician's manual for neurostimulation systems (available online at
medical.abbott/manuals).

For more information about MR Conditional products, visit the Abbott Medical
product information page at
neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html.

WARNINGS

The following warnings apply to this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are
poor surgical risks or patients with multiple illnesses or active general
infections.

Magnetic resonance imaging (MRI). Some patients may be implanted with the
components that make up a Magnetic Resonance (MR) Conditional system, which
allows them to receive an MRI scan if all the requirements for the implanted
components and for scanning are met. A physician can help determine if a patient
is eligible to receive an MRI scan by following the requirements provided by
Abbott Medical. Physicians should also discuss any risks of MRI with patients.

Patients without an MR Conditional neurostimulation system should not be
subjected to MRI because the electromagnetic field generated by an MRI may
damage the device electronics and induce voltage through the lead that could
jolt or shock the patient.

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or
therapeutic ultrasound diathermy (all now referred to as diathermy) on patients
implanted with a neurostimulation system. Energy from diathermy can be
transferred through the implanted system and cause tissue damage at the location
of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation
system components. This damage could result in loss of therapy, requiring
additional surgery for system implantation and replacement. Injury or damage can
occur during diathermy treatment whether the neurostimulation system is turned
on or off.

Electrosurgery. To avoid harming the patient or damaging the neurostimulation
system, do not use monopolar electrosurgery devices on patients with implanted
neurostimulation systems. Before using an electrosurgery device, place the
device in Surgery Mode using the patient controller app or clinician programmer
app. Confirm the neurostimulation system is functioning correctly after the
procedure.

* Use bipolar electrosurgery only.

* Complete any electrosurgery procedures before connecting the leads or
extensions to the neurostimulator.

* Keep the current paths from the electrosurgery device as far from the
neurostimulation system as possible.

* Set the electrosurgery device to the lowest possible energy setting.

* Confirm that the neurostimulation system is functioning correctly during the
implant procedure and before closing the neurostimulator pocket.

Implanted cardiac systems. Physicians need to be aware of the risk and possible
interaction between a neurostimulation system and an implanted cardiac system,
such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation
system may interact with the sensing operation of an implanted cardiac system,
causing the cardiac system to respond inappropriately. To minimize or prevent
the implanted cardiac system from sensing the output of the neurostimulation
system, (1) maximize the distance between the implanted systems; (2) verify that
the neurostimulation system is not interfering with the functions of the
implanted cardiac system; and (3) avoid programming either device in a unipolar
mode (using the device’s can as an anode) or using neurostimulation system
settings that interfere with the function of the implantable cardiac system.

Other active implanted devices. The neurostimulation system may interfere with
the normal operation of another active implanted device, such as a pacemaker,
defibrillator, or another type of neurostimulator. Conversely, the other active
implanted device may interfere with the operation of the neurostimulation
system.

Interference with other devices. Some of this system’s electronic equipment,
such as the programmer and controller, can radiate radiofrequency (RF) energy
that may interfere with other electronic devices, including other active
implanted devices. Avoid placing equipment components directly over other
electronic devices. To correct the effect of interference with other devices,
turn off the equipment or increase the distance between the equipment and the
device being affected.

Operation of machines, equipment, and vehicles. Patients using therapy that
generates paresthesia should turn off stimulation before operating motorized
vehicles, such as automobiles, or potentially dangerous machinery and equipment
because sudden stimulation changes may distract them from properly operating it.
However, current data shows that most patients using BurstDR™ stimulation
therapy do not experience paresthesia. For patients who do not feel paresthesia,
sudden stimulation changes are less likely to occur and distract them while
operating motorized vehicles, machinery, or equipment.

Explosive and flammable gasses. Do not use a clinician programmer or patient
controller in an environment where explosive or flammable gas fumes or vapors
are present. The operation of these devices could cause them to ignite, causing
severe burns, injury, or death.

Keep the device dry. Programmer and controller devices are not waterproof. Keep
them dry to avoid damage. Advise patients to not use their device when engaging
in activities that might cause it to get wet, such as swimming or bathing.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use
have not been established.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use
during pregnancy and nursing have not been established.

Use in patients with diabetes. Surgical complications and adverse effects may be
more frequent and severe in patients with diabetes. The following additional
considerations should be made for patients with diabetes:

* A pre-operative risk assessment should be performed for patients with
diabetes who are at high risk for ischemic heart disease, those with
autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C
(HbA1c) ≥8% (64 mmol/mol).
* Monitor the patient’s blood glucose levels in the perioperative period and
instruct the patient to continue to monitor glucose levels as they may
fluctuate as a response to surgery or to complications. Implanting physicians
or anesthesiologists should consult practice guidelines for the
intraoperative management of patients with diabetes.
* Closely monitor patients for signs of infection, delayed wound healing, or
cerebrospinal fluid (CSF) leakage as the severity of these complications may
be greater in patients with diabetes.

Stimulation modes. The BurstDR™ stimulation mode has not been evaluated for
effectiveness in the diabetic peripheral neuropathy (DPN) population.

Device components. The use of components not approved for use by Abbott Medical
with this system may result in damage to the system and increased risk to the
patient.

Device modification. Equipment is not serviceable by the customer. To prevent
injury or damage to the system, do not modify the equipment. If needed, return
the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the
operating system in any way. Do not use the application if the operating system
is compromised (that is, jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because
severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to Abbott Medical for safe disposal.
IPGs contain batteries as well as other potentially hazardous materials. Do not
crush, puncture, or burn the IPG because explosion or fire may result.

Product materials. Neurostimulation systems have materials that come in contact
or may come in contact with tissue. A physician should determine whether or not
a patient may have an allergic reaction to these materials before the system is
implanted.

PRECAUTIONS

The following precautions apply to this neurostimulation system.

GENERAL PRECAUTIONS

* Clinician training. Implanting physicians should be experienced in the
diagnosis and treatment of chronic pain syndromes and have undergone surgical
and device implantation training.

* Patient selection. It is extremely important to select patients appropriately
for neurostimulation. Thorough psychiatric screening should be performed.
Patients should not be dependent on drugs and should be able to operate the
neurostimulation system.

* Infection. Follow proper infection control procedures. Infections related to
system implantation might require that the device be explanted.

* Implantation of two systems. If two systems are implanted, ensure that at
least 20 cm (8 in.) separates the implanted IPGs to minimize unintended
interaction with other system components.

* Implantation of multiple leads. If multiple leads are implanted, leads and
extensions should be routed in close proximity. Nonadjacent leads can
possibly create a conduit for stray electromagnetic energy that could cause
the patient unwanted stimulation.

* Implant healing. While charging the generator, patients may perceive an
increase in temperature at the generator site. In patients who have areas of
increased sensitivity to heat, consider placing the implant where the patient
has normal sensation.

* High stimulation outputs. Stimulation at high outputs may cause unpleasant
sensations or motor disturbances, or render the patient incapable of
controlling the stimulator. If unpleasant sensations occur, the device should
be turned off immediately.

* Electromagnetic interference (EMI). Some equipment in home, work, medical,
and public environments can generate EMI that is strong enough to interfere
with the operation of a neurostimulation system or damage system
components. Patients should avoid getting too close to these types of EMI
sources, which include the following examples: commercial electrical
equipment (such as arc welders and induction furnaces), communication
equipment (such as microwave transmitters and high-power amateur
transmitters), high-voltage power lines, radiofrequency identification (RFID)
devices, and some medical procedures (such as therapeutic radiation and
electromagnetic lithotripsy).

* Consumer goods and electronic devices. Magnetic interference with consumer
goods or electronic devices that contain magnets, such as mobile phones and
smart watches, may unintentionally cause the neurostimulation system to turn
on or turn off or affect communication between the device and generator;
however, it will not change the prescribed programmed parameters. Patients
should be advised to keep their mobile phones and smart watches at least 15
cm (6 in.) away from the generator and avoid placing any smart device in a
pocket near the generator. If a patient is concerned about a smart device
interacting with their neurostimulation system, consider disabling magnet
mode. For more information about setting the magnet mode, refer to the
clinician programmer manual or contact Technical Support.

* Lead movement. Patients should be instructed to avoid bending, twisting,
stretching, and lifting objects over 2 kg (5 lb.) six to eight weeks after
implantation of a neurostimulation system. Extension of the upper torso or
neck may cause lead movement and alter the stimulation field (especially with
leads in the cervical area), resulting in overstimulation or ineffective
stimulation.

* Patient training. Instruct patients to use their neurostimulation system only
after an authorized clinician has programmed the device and has trained the
patient how to control stimulation and safely use the system.

* Programmer use. Allow only authorized use of the clinician programmer to
avoid any programming changes that may injure a patient.

STERILIZATION AND STORAGE

* Single-use, sterile device. The implanted components of this neurostimulation
system are intended for a single use only. Sterile components in this kit
have been sterilized using ethylene oxide (EtO) gas before shipment and are
supplied in sterile packaging to permit direct introduction into the sterile
field. Do not resterilize or reimplant an explanted system for any reason.

* Storage environment. Store components and their packaging where they will not
come in contact with liquids of any kind.

HANDLING AND IMPLEMENTATION

* Expiration date. An expiration date (or “use-before” date) is printed on the
packaging. Do not use the system if the use-before date has expired.

* Recharge-by-date. A recharge‑by date is printed on the packaging. If this
date has been reached or has been exceeded before the date of implantation,
the generator should be charged prior to implantation.

* Handle the device with care. The clinician programmer and patient controller
are sensitive electronic devices that can be damaged by rough handling, such
as dropping them on the ground.

* Care and handling of components. Use extreme care when handling system
components prior to implantation. Excessive heat, excessive traction,
excessive bending, excessive twisting, or the use of sharp instruments may
damage and cause failure of the components.

* Package or component damage. Do not implant a device if the sterile package
or components show signs of damage, if the sterile seal is ruptured, or if
contamination is suspected for any reason. Return any suspect components to
Abbott Medical for evaluation.

* Exposure to body fluids or saline. Prior to connection, exposure of the metal
contacts, such as those on the connection end of a lead or extension, to body
fluids or saline can lead to corrosion. If such exposure occurs, clean the
affected parts with sterile, deionized water or sterile water for irrigation,
and dry them completely prior to lead connection and implantation.

* System testing. To ensure correct operation, always test the system during
the implant procedure, before closing the neurostimulator pocket, and before
the patient leaves the surgery suite.

HOSPITALS AND MEDICAL ENVIRONMENTS

* High-output ultrasonics and lithotripsy. The use of high-output devices, such
as an electrohydraulic lithotripter, may cause damage to the electronic
circuitry of an implanted IPG. If lithotripsy must be used, do not focus the
energy near the IPG.

* Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may
cause mechanical damage to an implanted neurostimulation system if used
directly over the implanted system.

* External defibrillators. The safety of discharge of an external defibrillator
on patients with implanted neurostimulation systems has not been established.

* Therapeutic radiation. Therapeutic radiation may damage the electronic
circuitry of an implanted neurostimulation system, although no testing has
been done and no definite information on radiation effects is available.
Sources of therapeutic radiation include therapeutic X-rays, cobalt machines,
and linear accelerators. If radiation therapy is required, the area over the
implanted IPG should be shielded with lead. Damage to the system may not be
immediately detectable.

HOME AND OCCUPATIONAL ENVIRONMENTS

* Security, antitheft, and radiofrequency identification (RFID) devices. Some
antitheft devices, such as those used at entrances or exits of department
stores, libraries, and other public places, and airport security screening
devices may affect stimulation. Additionally, RFID devices, which are often
used to read identification badges, as well as some tag deactivation devices,
such as those used at payment counters at stores and loan desks at libraries,
may also affect stimulation.
Patients who are implanted with nonadjacent multiple leads and patients who
are sensitive to low stimulation thresholds may experience a momentary
increase in their perceived stimulation, which some patients have described
as uncomfortable or jolting. Patients should cautiously approach such devices
and should request help to bypass them. If they must go through a gate or
doorway containing this type of device, patients should turn off their IPG
and proceed with caution, being sure to move through the device quickly.

* Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100
ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute
(ATA). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could
damage the neurostimulation system. Before diving or using a hyperbaric
chamber, patients should discuss the effects of high pressure with their
physician.

* Wireless use restrictions. In some environments, the use of wireless
functions (for example, Bluetooth® wireless technology) may be restricted.
Such restrictions may apply aboard airplanes, in hospitals, near explosives,
or in hazardous locations. If you are unsure of the policy that applies to
the use of this device, please ask for authorization to use it before turning
it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

ADVERSE EFFECTS

In addition to those risks commonly associated with surgery, the following risks
are associated with implanting or using this neurostimulation system:

* Unpleasant sensations or motor disturbances, including involuntary movement,
caused by stimulation at high outputs; if either occurs, turn off your IPG
immediately

* Undesirable changes in stimulation, which may be related to cellular changes
in tissue around the electrodes, changes in electrode position, loose
electrical connections, or lead failure

* Stimulation in unwanted places (such as radicular stimulation of the chest
wall)

* Lead migration, causing changes in stimulation or reduced pain relief

* Epidural hemorrhage, hematoma, infection, spinal cord compression, or
paralysis from placement of a lead in the epidural space

* Cerebrospinal fluid (CSF) leakage

* Paralysis, weakness, clumsiness, numbness, or pain below the level of the
implant

* Persistent pain at the electrode or IPG site

* Seroma (mass or swelling) at the IPG site

* Allergic or rejection response to implant materials

* Implant migration or skin erosion around the implant

* Battery failure

* Changes in blood glucose levels in response to any adverse effect

NOTE: Patients with diabetes may have increased risks of infection, problems
healing around the surgical site, and complications common to any surgical
procedure. The severity of any surgical complication may be greater in
patients with diabetes, particularly those with inadequate preoperative
glycemic control. For adverse effects observed in the use of diabetic
peripheral neuropathy, refer to the clinical summaries manual for SCS
systems.

SAFETY AND EFFECTIVENESS STUDIES

For information that supports the clinical use of this neurostimulation system,
refer to the clinical summaries manual for spinal cord stimulation (SCS) systems
(available online at medical.abbott/manuals). This neurostimulation system is
similar in technology and intended use to the systems reported in the literature
and clinical studies. Therefore, the literature and clinical studies represent
the safety and effectiveness of this neurostimulation system.

21 CR 801.109(b) The label of the device, other than surgical instruments,
bears:

(1) The symbol statement “Rx only” or “℞ only” or the statement “Caution:
Federal law restricts this device to sale by or on the order of a ___”, the
blank to be filled with the word “physician,” “dentist,” “veterinarian,” or with
the descriptive designation of any other practitioner licensed by the law of the
State in which the practitioner practices to use or order the use of the device;
and

(2) The method of its application or use.

23-78280 MAT-2215216 v4.0 | Item approved for U.S. use only.

DORSAL ROOT GANGLION THERAPY (DRG) THERAPY

PRESCRIPTION AND SAFETY INFORMATION

Read this section to gather important prescription and safety information. For
specific indications, contraindications, instructions, warnings, precautions,
and adverse effects about system components available in your country or region,
see the approved clinician's manual for those components.

INTENDED USE

INDICATIONS FOR USE

This neurostimulation system is indicated for spinal column stimulation via
epidural and intraspinal lead access to the dorsal root ganglion as an aid in
the management of moderate to severe chronic intractable* pain of the lower
limbs in adult patients with complex regional pain syndrome (CRPS) types I and
II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate
pain relief from at least two prior pharmacologic treatments from at least two
different drug classes and continued their pharmacologic therapy during the
clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered
by the International Association for the Study of Pain (IASP) reviewed
diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and
causalgia as complex regional pain syndrome (CRPS) types I and II, respectively.
CRPS II (causalgia) is defined as a painful condition arising from damage to a
nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes
secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a
diagnostic requirement for CRPS II (causalgia).

CONTRAINDICATIONS

This neurostimulation system is contraindicated for patients who are

* Unable to operate the system

* Poor surgical risks

Patients who failed to receive effective pain relief during trial stimulation
are contraindicated to process to the permanent implant procedure.

MRI SAFETY INFORMATION

For more information about MR Conditional products, visit the Abbott Medical
product information page
at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html.

WARNINGS

The following warnings apply to this neurostimulation system.

Clinician training. Implanting physicians should be experienced in the diagnosis
and treatment of chronic pain syndromes and have undergone surgical and device
implantation training for dorsal root ganglion (DRG) neurostimulation systems.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use
during pregnancy and nursing have not been established.

Pediatric use. The safety and effectiveness of neurostimulation for pediatric
use have not been established.

Back pain. The safety and efficacy for the treatment of patients who have back
pain as the greatest region of pain have not been evaluated.

External defibrillators. Safety for use of external defibrillator discharges on
a patient receiving neurostimulation has not been established. External
defibrillation can cause induced currents in the lead-extension portion of the
neurostimulation system. After defibrillation, confirm the neurostimulation
system is still working.

Patients without an MR Conditional neurostimulation system should not be
subjected to MRI because the electromagnetic field generated by an MRI may
damage the device electronics, cause heating at the lead tip that could result
in tissue damage, and induce voltage through the lead that could jolt or shock
the patient.

Computed tomography (CT). If the patient requires a CT scan, all stimulation
should be turned off before the procedure. If stimulation is not turned off, the
patient may experience a momentary increase in stimulation, which may be
uncomfortable. Before beginning a CT scan, the operator should use CT scout
views to determine if implanted or externally worn electronic medical devices
are present and if so, their location relative to the programmed scan range.

* For CT procedures in which the medical device is in or immediately adjacent
to the programmed scan range, the operator should:

* Determine the device type

* If practical, try to move external devices out of the scan range

* Ask patients with neurostimulators to shut off the device temporarily while
the scan is performed.

* Minimize X-ray exposure to the implanted or externally worn electronic
medical device by using the lowest possible X-ray tube current consistent
with obtaining the required image quality and by making sure that the X-ray
beam does not dwell over the device for more than a few seconds.

Important note: For CT procedures that require scanning over the medical device
continuously for more than a few seconds, as with CT perfusion or interventional
exams, attending staff should be ready to take emergency measures to treat
adverse reactions if they occur.

After CT scanning directly over the implanted or externally worn electronic
medical device:

* Have the patient turn the device back on if it had been turned off prior to
scanning.

* Have the patient check the device for proper functioning, even if the device
was turned off.

* Advise patients to contact their healthcare provider as soon as possible if
they suspect their device is not functioning properly after a CT scan.

During implant procedures, if electrosurgery devices must be used, take the
following actions:

* Use bipolar electrosurgery only.

* Complete any electrosurgery procedures before connecting the leads or
extensions to the neurostimulator.

* Keep the current paths from the electrosurgery device as far from the
neurostimulation system as possible.

* Set the electrosurgery device to the lowest possible energy setting.

* Confirm that the neurostimulation system is functioning correctly during the
implant procedure and before closing the neurostimulator pocket.

1. Maximize the distance between the implanted systems;

2. Verify that the neurostimulation system is not interfering with the
functions of the implanted cardiac system; and

3. Avoid programming either device in a unipolar mode (using the device’s can
as an anode) or using neurostimulation system settings that interfere with
the function of the implantable cardiac system

Other active implantable devices. The effect of other implanted devices,
including deep brain stimulators, peripheral nerve stimulators, implanted drug
delivery pumps, and cochlear implants on the neurostimulation system are
unknown.

Radiofrequency or microwave ablation. Safety has not been established for
radiofrequency (RF) or microwave ablation in patients who have an implanted
neurostimulation system. Induced electrical currents may cause heating,
especially at the lead electrode site, resulting in tissue damage.

Emergency procedures. Instruct patients to designate a representative (family
member or close friend) to notify any emergency medical personnel of their
implanted neurostimulation system if emergency care is required. Patients will
receive an identification card to carry with them that will inform emergency
medical personnel of their implanted system. Advise patients to use caution when
undergoing any procedure that could include radiofrequency (RF) or microwave
ablation, defibrillation, or cardioversion.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may
cause mechanical damage to an implanted neurostimulation system if used directly
over the implanted system.

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry
of an implanted neurostimulation system, although no testing has been done and
no definite information on radiation effects is available. Sources of
therapeutic radiation include therapeutic X rays, cobalt machines, and linear
accelerators. If radiation therapy is required, the area over the implanted IPG
should be shielded with lead. Damage to the system may not be immediately
detectable.

Restricted areas. Warn patients to seek medical guidance before entering
environments that could adversely affect the operation of the implanted device,
including areas protected by a warning notice preventing entry by patients
fitted with a pacemaker.

Component manipulation by patients. The patient must be instructed to not rub or
exert pressure on implanted components through the skin as this may cause lead
dislodgement leading to stimulation at the implant site, IPG inversion leading
to the inability to communicate with the device, or skin erosion that can lead
to another surgical procedure or possible infection.

Implantation at vertebral levels above T10. The safety and efficacy of
implantation of leads implanted above the T10 vertebral level have not been
evaluated.

Number of leads implanted. The safety and efficacy of the implantation of
greater than four leads have not been evaluated.

Lead movement. Patients should be instructed to avoid bending, twisting,
stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after
implantation. These activities may cause lead movement, resulting in under
stimulation or overstimulation for the patient. Excessive lead migration may
require reoperation to replace the leads.

Scuba diving and hyperbaric chambers. Instruct patients to avoid scuba diving
and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because
these activities might damage the neurostimulation system.

Operation of machines, equipment, and vehicles. In the clinical experience with
this device, patients have experienced few effects when moving from lying down
to sitting up. Therefore, it is unlikely patients will need to adjust
stimulation when changing positions or moving.

However, advise patients who feel uncomfortable paresthesia during postural
changes that they should not operate potentially dangerous equipment such as
power tools, automobiles, or other motor vehicles. These patients should not
climb ladders or participate in activities where postural changes or abrupt
movements could alter the perception of stimulation intensity and cause patients
to fall or lose control of equipment or vehicles or injure others.

Device components. The use of components not approved for use by Abbott Medical
with this system may result in damage to the system and increased risk to the
patient.

Device modification. The equipment is not serviceable by the customer. To
prevent injury or damage to the system, do not modify the equipment. If needed,
return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the
operating system in any way. Do not use the application if the operating system
is compromised (i.e., jailbroken).

Case damage. Do not handle the IPG if the case is pierced or ruptured because
severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could
explode. Return the explanted IPG to Abbott Medical.

ADDITIONAL WARNINGS FOR LEADS

Conscious sedation. The placement of the leads involves some risk, as with any
surgical procedure. Conscious sedation can cause side effects such as systemic
toxicity, or cardiovascular or pulmonary problems. Use caution when sedating the
patient. The patient must be awake and conversant during the procedure to
minimize the likelihood of nerve damage.

Preventing infection. Always remove the trial leads before implanting the
implant leads to avoid the risk of infection that may cause death if the leads
are not removed. Use appropriate sterile technique when implanting leads and the
IPG.

Lead damage from tools. Use extreme care when using sharp instruments or
electrosurgery devices around the lead to avoid damaging the lead.

Needle positioning. Always be aware of the needle tip position. Use caution when
positioning the needle to avoid unintended injury to surrounding anatomical
structures.

Needle insertion. When using a contralateral approach, advance the needle slowly
into the epidural space and take caution as it enters. The needle will be
inserted at a steeper angle than in an antegrade approach and there is a greater
chance of dural puncture that will lead to a cerebrospinal fluid leak.

Advancing components. Use fluoroscopy and extreme care when inserting,
advancing, or manipulating the guidewire or lead in the epidural space to
minimize the risk of a dural tear. Dural puncture can occur if needle or
guidewire is advanced aggressively once loss of resistance is achieved. Advance
the needle and guidewire slowly. Do not use excessive force to push the lead or
sheath into the neural foramen as this may result in permanent or transient
nerve damage.

Removing components. Use extreme care when removing the lead stylet, the
delivery sheath, and the needle to ensure that the distal tip of the lead
remains in the desired location. Removing each item in slow movements while
holding the remaining components in place will assist this process.

Sheath insertion warning. Insertion of a sheath without the lead may result in
dural puncture. Securing the lead with the lead stabilizer will mitigate this
risk.

Sheath retraction. If the sheath needs to be retracted from the epidural space,
verify that the steering wing is rotated away from the needle mark no more than
90 degrees. Failure to do so may result in damage to the sheath. Before
reinserting the sheath, verify there is no damage to the sheath.

Sheath rotation. If the sheath is not responding to rotation, do not rotate the
steering wing out of plane from the curve of the sheath more than 90 degrees.
The tip of the sheath may whip around and could cause harm to the patient.

Lead insertion through sheath. If the lead is unable to deploy out of the
sheath, inject sterile water or saline slowly to release tissue that may have
entered between the sheath and the lead. Do not use excessive pressure when
injecting through the sheath.

Removing a kinked sheath. If the sheath has been kinked during delivery, slowly
retract through the needle with the curve facing the same direction as the
bevel. Failure to do so can damage or cut the lead or sheath. If resistance is
encountered, pull the needle out of the epidural space and then remove the
sheath.

Providing strain relief. Failure to provide strain relief may result in lead
migration requiring a revision procedure.

Anchoring leads. Do not suture directly onto the lead to avoid damaging the
lead. Failure to appropriately anchor the lead may cause lead migration, motor
activation, or painful stimulation.

Remove leads slowly. Remove leads slowly (at a suggested rate of 1 cm/s while
holding the lead between the thumb and forefinger) to avoid breaking the lead
and leaving fragments in the patient. If resistance is met while removing leads
from the epidural space, do not use excessive force to extract. Always perform
removal with the patient conscious and able to give feedback.

PRECAUTIONS

The following precautions apply to this neurostimulation system.

GENERAL PRECAUTIONS

* Infection. Follow proper infection control procedures. Infections related to
system implantation might require that the device be explanted.

* Implantation of multiple leads. If multiple leads or extensions are
implanted, the leads and extensions should be routed in close proximity.
Nonadjacent leads and extensions have the possibility of creating a conduit
for stray electromagnetic energy that could cause the patient unwanted
stimulation.

* Postural changes. In the clinical experience with this device, patients have
experienced few effects when moving from lying down to sitting up. Therefore,
it is unlikely patients will need to adjust stimulation when changing
positions or moving. However, some patients may experience a decrease or
increase in the perceived level of stimulation. Perception of higher levels
of stimulation has been described by some patients as uncomfortable, painful,
or jolting.

Advise patients who experience these types of stimulation changes to turn
down the amplitude or turn off the IPG before making extreme posture changes
or abrupt movements such as stretching, lifting their arms over their heads,
or exercising. If unpleasant sensations occur, the IPG should be turned off
immediately.

* Advise patients about adverse effects. Instruct patients to contact their
physician if they experience any adverse effects, such as unusual pain or
discomfort during stimulation and swelling, redness, tenderness, or pain
around implanted components.

* Programmer use. Allow only authorized use of the clinician programmer to
avoid any programming changes that may injure a patient.

* Battery precaution. The clinician programmer and patient controller contain a
battery and other potentially hazardous materials. Do not crush, puncture, or
burn these devices because explosion or fire may result. Return them to
Abbott Medical for proper disposal.

* Stimulation effectiveness. The long-term effectiveness of dorsal root
ganglion (DRG) stimulation has not been documented, and not all patients
realize the long-term benefits from DRG stimulation. Stimulation
effectiveness has been established for one year.

STERILIZATION AND STORAGE

* Storage environment. Store components and their packaging where they will not
come in contact with liquids of any kind.

HANDLING AND IMPLEMENTATION

* Expiration date. An expiration date (or “use-before” date) is printed on the
packaging. Do not use the system if the use-before date has expired.

* Package or component damage. Before opening any sterile package, verify the
kit model number, that the kit is within its expiration (use-before) date,
and that the packaging has not been damaged or compromised in any way. If the
packaging has been compromised, the device is beyond its expiration date, or
the sterile package or device show signs of damage, do not use the device as
it may be compromised and could cause harm to the patient. Return any suspect
components to Abbott Medical for evaluation.

* Handle the device with care. The clinician programmer and patient controller
are sensitive electronic devices that can be damaged by rough handling, such
as dropping them on the ground.

* Lead inspection. Carefully inspect the lead (in the sterile field) for damage
after removing it from the sterile package. Damage to the lead body can cause
improper function and stimulation or stimulation to areas other than the
intended target.

* Component handling. Do not bend, kink, or stretch the lead body, sheaths, or
other components as this may result in damage to the component and poor
function.

* Using surgical instruments. Do not use surgical instruments to handle the
lead. The force of the instruments may damage the lead or stylet.

* Using the tunneling tool. Use extreme care to not damage the lead with the
sharp point of the tunneling tool.

* Component manipulation. Do not over-manipulate the sheath and lead system as
this may result in trauma within the epidural space.

* Stylet handling. Do not bend, kink, or use surgical instruments on the
stylet, as this may damage it. Use care when reinserting a stylet. Too much
pressure on the stylet could damage the lead, resulting in intermittent or
loss of stimulation. Remove the stylet from the lead only when satisfied with
lead placement. If the stylet is removed from the lead, it may be difficult
to reinsert it.

* Sheath insertion precaution. Do not insert the sheath into the epidural space
without the lead or guidewire inserted, as this may cause injury to the dura.

* Stabilizing the lead during insertion. When inserting the lead-sheath
assembly through the needle into the epidural space, tighten the lead
stabilizer to prevent lead migration out of the sheath. Failure to do so may
cause harm to the patient such as damage to the dura.

* Bending the sheath. Do not bend the sheath without the lead inside the
sheath, as this will permanently kink it and make it difficult to deploy the
lead.

* Lead handling. If the operating field is bloody, wipe gloves, lead, stylet,
and sheath before handling the lead. Failure to do so may result in
difficulty delivering the lead.

* Inserting the anchor. Failure to push the short end of the soft tissue anchor
into the ligament or fascia may result in lead migration and a procedure to
revise the lead location.

* Securing the anchor. Use caution when securing the soft tissue anchor because
damage to the anchor or lead can occur and result in failure of the system.

* Placing the IPG. Do not place the IPG deeper than 4.0 cm (1.57 in) because
the clinician programmer or patient controller may not communicate
effectively with the IPG.

* Securing the IPG. Do not bring the suture needle in contact with an IPG,
lead, or extension, or the component may be damaged.

* System testing. To ensure correct operation, always test the system during
the implant procedure, before closing the neurostimulator pocket, and before
the patient leaves the surgery suite.

* Conscious sedation during removal. Always perform removal of implanted
components with the patient conscious and able to give feedback.

* Surgical advice for removal. If resistance is met while removing leads from
the epidural space, do not use excessive force to extract. Consider seeking
surgical advice if you cannot easily remove a lead.

* Component disposal. Return all explanted components to Abbott Medical for
safe disposal.

HOSPITAL AND MEDICAL ENVIRONMENTS

* High-output ultrasonics and lithotripsy. The use of high-output devices, such
as an electrohydraulic lithotriptor, may cause damage to the electronic
circuitry of an implanted IPG. If lithotripsy must be used, do not focus the
energy near the IPG.

* Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT).
Safety has not been established for TMS or ECT in patients who have an
implanted neurostimulation system. Induced electrical currents may cause
heating, especially at the lead electrode site, resulting in tissue damage.

* Transcutaneous electrical nerve stimulation (TENS). Do not place TENS
electrodes so that the TENS current passes over any part of the
neurostimulation system. If patients feel that the TENS device may be
interfering with the neurostimulator, patients should discontinue using the
TENS device until they talk with their physician.

HOME AND OCCUPATIONAL ENVIRONMENTS

* commercial electrical equipment (such as arc welders and induction
furnaces)

* communication equipment (such as microwave transmitters and high-power
amateur transmitters)

* high-voltage power lines

* radiofrequency identification (RFID) devices

* some medical procedures (such as therapeutic radiation, static magnetic
field [SMF] therapy, and electromagnetic lithotripsy)

* and some medical devices (such as bone growth stimulators, transcutaneous
electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic
probes)

* Interference with wireless equipment. Wireless communications equipment, such
as mobile and cordless phones and walkie-talkies, may interfere with the IPG
if the equipment gets too close to the IPG. To correct the effects of typical
interference, keep wireless communication equipment at least 15 cm (6 in)
from the IPG.

* Wireless use restrictions. In some environments, the use of wireless
functions (e.g., Bluetooth® wireless technology) may be restricted. Such
restrictions may apply aboard airplanes, in hospitals, near explosives, or in
hazardous locations. If you are unsure of the policy that applies to the use
of this device, please ask for authorization to use it before turning it on.
(Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)

Additionally, RFID devices, which are often used to read identification
badges, as well as some tag deactivation devices, such as those used at
payment counters at stores and loan desks at libraries, may also affect
stimulation.

Patients who are implanted with nonadjacent multiple leads and patients who
are sensitive to low stimulation thresholds may experience a momentary
increase in their perceived stimulation, which some patients have described
as uncomfortable or jolting. Patients should cautiously approach such devices
and should request help to bypass them. If they must go through a gate or
doorway containing this type of device, patients should turn off their IPG
and proceed with caution, being sure to move through the device quickly.

* Overcommunicating with the IPG. Advise patients to use their patient
controller to communicate with their IPG only when needed because excessive
communication with the IPG can shorten the remaining battery life.

* Mobile phones. While interference with mobile phones is not anticipated,
technology continues to change and interaction between a neurostimulation
system and a mobile phone is possible. Advise patients to contact their
physician if they are concerned about their mobile phone interacting with
their neurostimulation system.

ADVERSE EFFECTS

In addition to those risks commonly associated with surgery, the following risks
are associated with using this neurostimulation system:

* Unpleasant sensations or motor disturbances, including involuntary movement,
caused by stimulation at high outputs (if either occurs, turn off your IPG
immediately.)

* Undesirable changes in stimulation, which may be related to cellular changes
in tissue around the electrodes, changes in electrode position, loose
electrical connections, or lead failure or breakage

* Stimulation in unwanted places (such as stimulation of the chest wall)

* Lead migration, causing changes in stimulation or reduced pain relief

* Epidural hemorrhage, hematoma, infection, spinal cord compression, or
paralysis from placement of a lead in the epidural space Cerebrospinal fluid
(CSF) leakage

* Tissue damage or nerve damage

* Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the
level of the implant

* Pain or bleeding where the needle was inserted

* Persistent pain at the electrode or IPG site

* Escalating pain

* Seroma (mass or swelling) at the implant site

* Headache

* Allergic or rejection response to device or implant materials

* Implant migration or skin erosion around the implant

* Battery failure, leakage, or both

* Hardware malfunction that requires replacing the neurostimulator

* Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain

* Formation of reactive tissue in the epidural space around the lead, which can
cause delayed spinal cord compression and paralysis and requires surgical
intervention (Time to onset can range 23 from weeks to many years after
implant.)

Additional risks to the patients, as a result of the placement and stimulation
of the lead in the area of the dorsal root ganglion (DRG), include pain from
setting the stimulation parameters too high. This may occur once the lead is in
place and is connected to the neurostimulator and activated. The neurostimulator
is controlled by a trained operator and the starting point for the stimulation
will be set to the lowest available settings. Additionally, all patients will be
awake and conversant during the procedure to minimize the impact.

71376 MAT-2006974 v2.0 | Item approved for U.S. use only.

DEEP BRAIN STIMULATION (DBS) THERAPY

INTENDED USE

INDICATIONS FOR USE

The Abbott Medical deep brain stimulation system is indicated for the following
conditions:

* Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus
pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of
advanced levodopa-responsive Parkinson’s disease that are not adequately
controlled by medications.
* Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM)
of the thalamus for the suppression of disabling upper extremity tremor in
adult essential tremor patients whose tremor is not adequately controlled by
medications and where the tremor constitutes a significant functional
disability.

CONTRAINDICATIONS

This system is contraindicated for patients who meet the following criteria:

* Are unable to operate the system

* Have unsuccessful test stimulation

The following procedures are contraindicated for patients with a deep brain
stimulation system. Advise patients to inform their healthcare professional that
they cannot undergo the following procedures:

* Diathermy (short-wave diathermy, microwave diathermy, or therapeutic
ultrasound diathermy)

* Electroshock therapy and transcranial magnetic stimulation (TMS)

MRI SAFETY INFORMATION

Some models of this system are Magnetic Resonance (MR) Conditional, and patients
with these devices may be scanned safely with magnetic resonance imaging (MRI)
when the conditions for safe scanning are met. For more information about MR
Conditional neurostimulation components and systems, including equipment
settings, scanning procedures, and a complete listing of conditionally approved
components, refer to the MRI procedures clinician's manual for neurostimulation
systems (available online at medical.abbott/manuals). For more information about
MR Conditional products, visit the Abbott Medical product information page at
neuromodulation.abbott/MRI-ready.

WARNINGS

The following warnings apply to this neurostimulation system.

Pregnancy and nursing. Safety and effectiveness of neurostimulation for use
during pregnancy and nursing have not been established. Patients should not use
this neurostimulation system if they are pregnant or nursing.

High stimulation outputs and charge density limits. Avoid excessive stimulation.
A risk of brain tissue damage exists with parameter settings using high
amplitudes and wide pulse widths.

High amplitudes and wide pulse widths should only be programmed with due
consideration of the warnings concerning charge densities. The system can be
programmed to use parameter settings outside the range of those used in the
clinical studies. If the programming of stimulation parameters exceeds the
charge density limit of 30 μC/cm2, a screen will appear warning you that the
charge density is too high. Charge density can be reduced by lowering the
stimulation amplitude or pulse width. For more information, see the clinician
programmer manual.

Higher amplitudes and wider pulse widths may indicate a system problem or a
suboptimal lead placement. Stimulation at high outputs may cause unpleasant
sensations or motor disturbances or may render the patient incapable of
controlling the patient controller. If unpleasant sensations occur, the device
should be turned off immediately using the patient magnet.

Risk of depression, suicidal ideations, and suicide. New onset or worsening
depression, which may be temporary or permanent, is a risk that has been
reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are
events that have also been reported. Therefore, physicians should consider the
following:

* Preoperatively, assess patients for the risks of depression and suicide. This
assessment should consider both the risk of depression and suicide as well as
the potential clinical benefits of DBS therapy for the condition being
treated.

* Postoperatively, actively monitor patients for new or worsening symptoms of
depression, suicidal thoughts or behaviors, or changes in mood or impulse
control.

* If a patient experiences new or worsening depression or suicidal ideation,
manage these symptoms appropriately.

* Educate patients and caregivers about these potential risks prior to
implantation, and be sure that they know about the importance of ongoing
support and follow-up, including when to contact their health care provider.

Poor surgical risks. Neurostimulation should not be used on patients who are
poor surgical risks or patients with multiple illnesses or active general
infections.

Explosive or flammable gasses. Do not use the clinician programmer or patient
controller in an environment where explosive or flammable gas fumes or vapors
are present. The operation of the clinician programmer or patient controller
could cause them to ignite, causing severe burns, injury, or death.

Operation of machinery and equipment. Patients should not operate potentially
dangerous machinery, power tools, or vehicles or engage in any activity that
could be unsafe if their symptoms were to unexpectedly return.

Pediatric use. Safety and effectiveness of neurostimulation for pediatric use
have not been established.

Device components. The use of components not approved for use by Abbott Medical
with this system may result in damage to the system and increased risk to the
patient.

Device modification. This equipment is not serviceable by the customer. To
prevent injury or damage to the system, do not modify the equipment. If needed,
return the equipment to Abbott Medical for service.

Application modification. To prevent unintended stimulation, do not modify the
generator software in any way. Only apply software updates that are published
directly by Abbott Medical.

During implant procedures, if electrosurgery devices must be used, take the
following actions:

* Use bipolar electrosurgery only.

* Complete any electrosurgery procedures before connecting the leads or
extensions to the neurostimulator.

* Keep the current paths from the electrosurgery device as far from the
neurostimulation system as possible.

* Exit Surgery Mode during intraoperative testing and after the procedure is
completed. NOTE: During intraoperative testing, Surgery Mode must be turned
off for the neurostimulation system to function correctly.

* Confirm that the neurostimulation system is functioning correctly during the
implant procedure and before closing the neurostimulator pocket.

After any surgery, check the neurostimulation system for the following:

* Check the neurostimulator to ensure Surgery Mode has been turned off, even if
Surgery Mode was not turned on at the beginning or during the procedure.

* Confirm the neurostimulation system is functioning

Radiofrequency or microwave ablation. Careful consideration should be used
before using radiofrequency (RF) or microwave ablation in patients who have an
implanted neurostimulation system since safety has not been established. Induced
electrical currents may cause heating, especially at the lead electrode site,
resulting in tissue damage.

1. Maximize the distance between the implanted systems;

2. Verify that the neurostimulation system is not interfering with the
functions of the implanted cardiac system; and

Case damage. If the case of the implantable pulse generator (IPG) is pierced or
ruptured, severe burns could result from exposure to battery chemicals.

Cremation. The IPG should be explanted before cremation because the IPG could
explode. Return the explanted IPG to Abbott Medical.

Generator disposal. Return all explanted components to Abbott Medical for safe
disposal. IPGs contain batteries as well as other potentially hazardous
materials. Do not crush, puncture, or burn the IPG because explosion or fire may
result.

Coagulopathies. Physicians should use extreme care with lead implantation in
patients with a heightened risk of intracranial hemorrhage. Physicians should
also consider underlying factors, such as previous neurological injury or
prescribed medications (anticoagulants), that may predispose a patient to the
risk of bleeding.

Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to
be driven (meaning that tremor occurs at the same frequency as the programmed
frequency). For this reason, programming at frequencies less than 30 Hz is not
recommended.

Return of symptoms and rebound effect. The abrupt cessation of stimulation for
any reason will probably cause disease symptoms to return. In some cases,
symptoms may return with a greater intensity than what a patient experienced
before system implantation (rebound effect). In rare cases, this can create a
medical emergency.

PRECAUTIONS

The following precautions apply to this neurostimulation system.

GENERAL PRECAUTIONS

Surgeon training. Implanting physicians should be experienced in stereotactic
and functional neurosurgery.

Clinician training. Clinicians should be familiar with deep brain stimulation
therapy and be experienced in the diagnosis and treatment of the indication for
which the deep brain stimulation components are being used.

Patient training. Instruct patients to use their neurostimulation system only
after an authorized clinician has programmed the generator and has trained the
patient on how to safely control stimulation and to charge the system

Patient selection. Select patients appropriately for deep brain stimulation. The
patient should be able and willing to use the patient controller and correctly
interpret the icons and messages that appear on the screen.

Especially consider the following additional factors when selecting patients:

* Level of available support from a caregiver.

* Expected effect from cessation of therapy, should disease symptoms return
unexpectedly.

* Patient's age, as very young or very old patients may have difficulty
performing required monitoring of the device.

* Patient's mental capacity, as patients with cognitive impairment or those
prone to developing dementia would likely have difficulty performing
device-related tasks without assistance.

* Patient's physical ability, as patients with higher degrees of motor
impairment might have difficulty with the physical requirements of monitoring
the device.

* Patient's visual ability to read the patient controller screen.

Infection. Follow proper infection control procedures. Infections may require
that the device be explanted.

Implantation of two systems. If two systems are implanted, ensure that at least
20 cm (8 in.) separates the implanted generators to minimize unintended
interaction with other system components.

Implantation of multiple leads. If multiple leads are implanted, leads and
extensions should be routed in close proximity. Nonadjacent leads can possibly
create a conduit for stray electromagnetic energy that could cause the patient
unwanted stimulation.

Implant heating. While charging the generator, patients may perceive an increase
in temperature at the generator site. In patients who have areas of increased
sensitivity to heat, consider placing the implant where the patient has normal
sensation.

Electromagnetic interference (EMI). Some equipment in home, work, medical, and
public environments can generate EMI that is strong enough to interfere with the
operation of a neurostimulation system or damage system components. Patients
should avoid getting too close to these types of EMI sources, which include the
following examples:

* Commercial electrical equipment (such as arc welders and induction
furnaces),

* Communication equipment (such as microwave transmitters and high-power
amateur transmitters),

* High-voltage power lines,

* Radiofrequency identification (RFID) devices,

* And some medical procedures (such as therapeutic radiation and
electromagnetic lithotripsy).

Programmer use. Allow only authorized use of the clinician programmer to avoid
any programming changes that may injure a patient.

Security, antitheft, and radiofrequency identification (RFID) devices. Some
antitheft devices, such as those used at entrances or exits of department
stores, libraries, and other public places, and airport security screening
devices may affect stimulation. Additionally, RFID devices, which are often used
to read identification badges, as well as some tag deactivation devices, such as
those used at payment counters at stores and loan desks at libraries, may also
affect stimulation.

Patients should cautiously approach such devices and should request help to
bypass them. If they must go through or near a gate or doorway containing this
type of device, patients should move quickly and then check their IPG to
determine if it is turned on or off.

Unauthorized changes to stimulation parameters. Caution patients to not make
unauthorized changes to physician-established stimulation parameters.

Damage to shallow implants. Falling and other traumatic accidents can damage
shallowly implanted components such as the leads and extensions.

Keep programmers and controllers dry. The clinician programmer and patient
controller are not waterproof. Keep them dry to avoid damage. Advise patients to
not use the patient controller when engaging in activities that might cause it
to get wet, such as swimming or bathing.

Handle the programmers and controllers with care. The clinician programmer and
patient controllers are sensitive electronic devices that can be damaged by
rough handling, such as dropping them on the ground.

Battery care. Batteries can explode, leak, or melt if disassembled, shorted
(when battery connections contact metal), or exposed to high temperature or
fire.

Long-term safety and effectiveness. The long-term safety and effectiveness of
this neurostimulation system has not been established beyond 5 years. Safety and
effectiveness has not been established for patients with a neurological disease
other than Parkinson’s disease or essential tremor, previous surgical ablation
procedures, dementia, coagulopathies, or moderate to severe depression; patients
under 22 years; implantation in targets other than the STN for Parkinson's
disease and the VIM for essential tremor; patients with an active implantable
device; patients requiring MRI.

STERILIZATION AND STORAGE

Single-use, sterile device. The implanted components of this neurostimulation
system are intended for a single use only. Sterile components in this kit have
been sterilized using ethylene oxide (EtO) gas before shipment and are supplied
in sterile packaging to permit direct introduction into the sterile field. Do
not resterilize or reimplant an explanted system for any reason.

Storage environment. Store components and their packaging where they will not
come in contact with liquids of any kind. Detailed information on storage
environment is provided in the appendix of this manual.

HANDLING AND IMPLANTATION

Expiration date. An expiration date (or “use-before” date) is printed on the
packaging. Do not use the system if the use-before date has expired.

Recharge. Recharge information is printed on the packaging, which instructs the
user to fully charge the generator before implantation.

Handle devices with care. The clinician programmer and patient controller are
sensitive electronic devices that can be damaged by rough handling, such as
dropping them on the ground.

Care and handling of components. Use extreme care when handling system
components. Excessive heat, excessive traction, excessive bending, excessive
twisting, or the use of sharp instruments may damage and cause failure of the
components.

Package or component damage. Do not implant a device if the sterile package or
components show signs of damage, if the sterile seal is ruptured, or if
contamination is suspected for any reason. Return any suspect components to
Abbott Medical for evaluation.

Exposure to body fluids or saline. Prior to connection, exposure of the metal
contacts, such as those on the connection end of a lead or extension, to body
fluids or saline can lead to corrosion. If such exposure occurs, clean the
affected parts with sterile, deionized water or sterile water for irrigation,
and dry them completely prior to lead connection and implantation.

Skin erosion. To avoid the risk of skin erosion, implant components at the
appropriate depth and inform patients to avoid touching their skin where
components are implanted. The IPG should be placed into the pocket, at a depth
not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin
surface.

System testing. To ensure correct operation, always test the system during the
implant procedure, before closing the neurostimulator pocket, and before the
patient leaves the surgery suite.

Multiple leads. When multiple leads are implanted, route the lead extensions so
the area between them is minimized. If the lead extensions are routed in a loop,
the loop will increase the potential for electromagnetic interference (EMI).

Abandoned leads and replacement leads. The long-term safety associated with
multiple implants, leads left in place without use, replacement of leads,
multiple implants into the target structure, and lead explant is unknown.

Placement of lead connection in neck. The lead-extension connector should not be
placed in the soft tissues of the neck due to an increased incidence of lead
fracture.

HOSPITAL AND MEDICAL ENVIRONMENTS

Electrical medical treatment. In the case that a medical treatment is
administered where an electrical current is passed through the body from an
external source, first deactivate the IPG by setting all electrodes to off,
turning stimulation off, and setting amplitude to zero. Regardless if the device
is deactivated, take care to monitor the device for proper function during and
after treatment.

High-output ultrasonics and lithotripsy. The use of high-output devices, such as
an electrohydraulic lithotriptor, may cause damage to the electronic circuitry
of an implanted IPG. If lithotripsy must be used, do not focus the energy near
the IPG.

Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may
cause mechanical damage to an implanted neurostimulation system if used directly
over the implanted system.

External defibrillators. The safety of discharge of an external defibrillator on
patients with implanted neurostimulation systems has not been established.

Electrocardiograms. Ensure the neurostimulator is off before initiating an
electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG
recording may be adversely affected, resulting in inaccurate ECG results.
Inaccurate ECG results may lead to inappropriate treatment of the patient.

HOME AND OCCUPATIONAL ENVIRONMENTS

Patient activities and environmental precautions. Patients should take
reasonable care to avoid devices that generate strong EMI, which may cause the
neurostimulation system to unintentionally turn on or off. Patients should also
avoid any activities that would be potentially unsafe if their symptoms were to
return unexpectedly. These activities include but are not limited to climbing
ladders and operating potentially dangerous machinery, power tools, and
vehicles. Sudden loss of stimulation may cause patients to fall or lose control
of equipment or vehicles, injure others, or bring injury upon themselves.

Control of the patient controller. Advise patients to keep the patient
controller away from children and pets in order to avoid potential damage or
other hazards.

Activities requiring excessive twisting or stretching. Patients should avoid
activities that may put undue stress on the implanted components of the
neurostimulation system. Activities that include sudden, excessive or repetitive
bending, twisting, or stretching can cause component fracture or dislodgement.
Component fracture or dislodgement may result in loss of stimulation,
intermittent stimulation, stimulation at the fracture site, and additional
surgery to replace or reposition the component.

Activities requiring coordination. Loss of coordination is a potential side
effect of DBS therapy. Patients should exercise reasonable caution when
participating in activities that require coordination, including those that they
were able to perform prior to receiving DBS therapy (for example, swimming).

Bathing. Patients should exercise reasonable caution when bathing.

Component manipulation by patient. Advise your patient to avoid manipulating the
implanted system components (e.g., the neurostimulator, the burr hole site).
This can result in component damage, lead dislodgement, skin erosion, or
stimulation at the implant site. Manipulation may cause device inversion,
inhibiting the ability to use the magnet to start or stop stimulation.

Scuba diving or hyperbaric chambers. Patients should not dive below 30 m (100
ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA).
Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the
neurostimulation system. Before diving or using a hyperbaric chamber, patients
should discuss the effects of high pressure with their physician.

Skydiving, skiing, or hiking in the mountains. High altitudes should not affect
the neurostimulator; however, the patient should consider the movements involved
in any planned activity and take precautions to avoid putting undue stress on
the implanted system. Patients should be aware that during skydiving, the sudden
jerking that occurs when the parachute opens may cause lead dislodgement or
fractures, which may require surgery to repair or replace the lead.

Wireless use restrictions. In some environments, the use of wireless functions
(e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may
apply aboard airplanes, near explosives, or in hazardous locations. If you are
unsure of the policy that applies to the use of this device, please ask for
authorization to use it before turning it on. (Bluetooth® is a registered
trademark of Bluetooth SIG, Inc.)

Consumer goods and electronic devices. Magnetic interference with consumer
goods or electronic devices that contain magnets, such as mobile phones and
smart watches, may unintentionally cause the neurostimulation system to turn on
or turn off or affect communication between the device and generator however, it
will not change the prescribed programmed parameters. Patients should be advised
to keep their mobile phones and smart watches at least 15 cm (6 in.) away from
the generator and avoid placing any smart device in a pocket near the generator.
If a patient is concerned about a smart device interacting with their
neurostimulation system, consider disabling magnet mode. For more information
about setting the magnet mode, refer to the clinician programmer manual or
contact Technical Support.

Household appliances. Household appliances that contain magnets (e.g.,
refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones,
cordless telephones, standard wired telephones, AM/FM radios, and some power
tools) may unintentionally cause the neurostimulation system to turn on or turn
off.

Therapeutic magnets. Patients should be advised to not use therapeutic magnets.
Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts,
knee braces, wrist bands, and insoles) may unintentionally cause the
neurostimulation system to turn on or off.

ADVERSE EFFECTS

Deep brain stimulation potentially has the following adverse effects:

Possible surgical complications. Surgical complications include, but are not
limited to, the following:

* Intracranial hemorrhage (which can lead to stroke, paralysis, or death);

* Subcutaneous hemorrhage or seroma;

* Hematoma;

* Cerebrospinal fluid leakage or cerebrospinal fluid abnormality;

* Brain contusion;

* Infection or inflammation;

* Antibiotic anaphylaxis;

* Skin disorder;

* Edema;

* Persistent pain at surgery site or IPG site;

* Erosion;

* Brachial plexus injury (nerves to chest, shoulder and arm);

* Postoperative pain, stress, or discomfort;

* Neuropathy (nerve degeneration);

* Hemiparesis (muscular weakness or partial paralysis on one side of body);

* Ballism or hemiballism (uncontrollable movements on both or only one side of
the body);

* Confusion—transient, nocturnal or ongoing;

* Cognitive impairment, including delirium, dementia, disorientation, psychosis
and speech difficulties;

* Aphasia;

* Deep vein thrombosis;

* Complications from anesthesia;

* Phlebitis (vein inflammation);

* Pulmonary embolism (sudden blood vessel obstruction);

* Aborted procedures (air embolism, unable to find target, surgical
complication, etc.);

* Complications from unusual physiological variations in patients, including
foreign body rejection phenomena;

* Pneumonia, seizure or convulsions;

* Paralysis (loss of motor function, inability to move);

* Stroke and death.

Possible deep brain stimulation complications. Deep brain stimulation
complications include, but are not limited to, the following:

* Device-related complications

* Undesirable changes in stimulation related to cellular changes in tissue
around the electrodes, changes in the electrode position, loose electrical
connections, or lead fracture

* Loss of therapeutic benefit as a result of change in electrode positions,
loose electrical connections, or lead or extension fracture

* Initial jolt or tingling during stimulation; jolting or shocking sensations

* Infection

* Paresthesia

* Lead fracture, migration, or dislodgement

* Misplaced lead

* Extension malfunction, fracture, or disconnect

* Deep brain stimulation system failure or battery failure within the device

* Deep brain stimulation system malfunction or dislodgement

* Spontaneous turning on or off of the IPG

* Allergic or rejection response to implanted materials

* Persistent pain, tightness, or redness at the incision sites or general
pain

* General erosion or local skin erosion over the IPG

* Persistent pain, tightness, or discomfort around the implanted parts (e.g.,
along the extension path in the neck)

* Impaired wound healing (e.g., incision site drainage) or abscess formation

* Additional neurosurgical procedure to manage one of the above complications
or to replace a malfunctioning component

* Stimulation-related complications or other complications

* Worsening of motor impairment and Parkinson’s disease symptoms including
dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor
fluctuations, abnormal gait or incoordination, ataxia, tremor, and
dysphasia

* Paresis, asthenia, hemiplegia, or hemiparesis

* Dystonia

* Sensory disturbance or impairment including neuropathy, neuralgia, sensory
deficit, headache, and hearing and visual disturbance

* Speech or language impairment including, aphasia, dysphagia, dysarthria,
and hypophonia

* Cognitive impairment including attention deficit, confusion,
disorientation, abnormal thinking, hallucinations, amnesia, delusions,
dementia, inability to act or make decisions, psychic akinesia, long term
memory impairment, psychiatric disturbances, depression, irritability or
fatigue, mania or hypomania, psychosis, aggression, emotional lability,
sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation,
postural instability and disequilibrium

* Restless leg syndrome

* Supranuclear gaze palsy

* Hypersexuality or increased libido

* Decreased therapeutic response

* Urinary incontinence or retention

* Diarrhea or constipation

* Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope)

* Difficulty breathing

* Increased salivation

* Weight gain or loss

* Eye disorder including eye apraxia or blepharospasm

* Nausea or vomiting

* Sweating

* Fever

* Hiccups

* Cough

* Cramps

* Worsening existing medical conditions

23-86540 MAT-2215217 v3.0 | Item approved for U.S. use only.

24-94508 MAT-2303639 v3.0 | Item approved for U.S. use only.

PATIENT CONDITIONS

* Chronic Pain
* Parkinson's Disease
* Essential Tremor
* Diabetic Peripheral Neuropathy

HEALTHCARE PROFESSIONALS

* Chronic Pain
* Movement Disorders
* Education & Training
* MRI Support
* Reimbursement & Coding

PRODUCT SUPPORT

* Cybersecurity
* Important Safety Information
* Mobile OS Compatibility
* Product Advisories

POLICIES & PREFERENCES

* Advertising Preferences
* Privacy Policy
* Consumer Health Data Policy
* Terms & Conditions
* Cookie-Präferenzen

* Patients
* Healthcare Professionals

CHRONIC PAIN

PARKINSON'S DISEASE

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