Boston Scientific VERCISE DBS Owner's manual

92366224-01
Content: MP92366224-01 REV A
Vercise™ Deep Brain
Stimulation Systems
Information for
Prescribers
CAUTION: Federal law
restricts this device to sale,
distribution and use by or
on the order of a physician.

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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How to Use this Manual
This manual provides information about the Boston Scientic Deep Brain Stimulation (DBS)
System. Throughout this manual, the name “Boston Scientic DBS System” refers to the following
Systems: Vercise GenusTM, Vercise GeviaTM, and VerciseTM PC.
Read all instructions carefully before using the DBS System. For other device‑specic information
not included in this manual, refer to the appropriate DFU for your Boston Scientic DBS System as
listed in your DBS Reference Guide.
Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating
to its products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their respective holders.
The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc.
and any use of such marks by Boston Scientic Neuromodulation Corporation is under license.
Technical Support
There are no user serviceable parts. If you have a specic question or issue, please contact your
sales representative or call (833) DBS‑INFO or (833) 327‑4636.
Registration Information
Device registration information must be provided to Boston Scientic following device implantation.
The purpose of this registration is to maintain traceability of all products and to secure warranty
rights. It also allows the institution involved in the evaluation or replacement of a specic implanted
DBS Lead, accessory, or device to gain quick access to pertinent data from the manufacturer.
To complete device registration, follow the instructions provided by your local sales representative
or ll out the registration form included in the package contents. A device registration form is
included with each Boston Scientic DBS Lead, DBS Extension, and some DBS Stimulators.
Return one copy to the Boston Scientic Customer Service Department, keep one copy for patient
records, provide one copy to the patient, and save one copy for the physician.
Boston Scientic Neuromodulation Corporation
Attention: Customer Service Department
25155 Rye Canyon Loop
Valencia, CA 91355, USA
Patient Identication Card
Ensure that the patient receives a completed Temporary Identication Card after their surgery.
Permanent ID cards will be mailed directly to the patient following patient registration.

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Table of Contents
Device Description .......................................................................................... 1
Intended Use / Indications for Use .......................................................................... 1
Safety Information........................................................................................... 2
Contraindications..................................................................................................... 2
Warnings ................................................................................................................. 3
Precautions ............................................................................................................. 6
Adverse Events ....................................................................................................... 12
Service and Maintenance................................................................................ 14
External Trial Stimulator (ETS) Maintenance .......................................................... 14
Cleaning the Charging System................................................................................ 15
Cleaning the Remote Control.................................................................................. 15
Cleaning the Programming Wand ........................................................................... 15
Electromagnetic Compatibility....................................................................... 16
EN 60601‑1‑2 Classication Information................................................................. 16
Essential Performance ............................................................................................ 22
Telemetry Information.............................................................................................. 22
Quality of Wireless Service ..................................................................................... 23
Troubleshooting Wireless Coexistence Issues........................................................ 24
Wireless Security..................................................................................................... 25
FCC Compliance..................................................................................................... 27
Rechargeable Stimulator Battery................................................................... 28
Stimulator Battery.................................................................................................... 28
Recharge Estimate.................................................................................................. 28
Non‑Rechargeable Stimulator Battery........................................................... 29
Stimulator Battery.................................................................................................... 29
Elective Replacement.............................................................................................. 29
End of Service......................................................................................................... 29

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Device Description
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Device Description
The Boston Scientic Deep Brain Stimulation (DBS) System provides a reversible therapy where
structures in the brain are stimulated with small electrical pulses. A Boston Scientic DBS System
utilizes current steering (also known as multiple independent current control or MICC) across eight
or sixteen Contacts per DBS Lead to provide precise positioning of stimulation. The implantable
components of the Boston Scientic DBS System include the following:
• An Implantable Pulse Generator (IPG) that is either rechargeable or non‑rechargeable.
-The IPG is also referred to as a Stimulator.
• Leads that deliver electrical pulses to the brain.
• Lead Extensions that connect the Leads to the IPG.
• A Lead Boot to protect the proximal end of the Lead between surgeries.
• Sutures Sleeves to protect the Lead and/or to anchor the Leads and Lead Extensions.
• Port Plugs for unused IPG or Lead Extension ports.
• The Boston Scientic SureTekTM Burr Hole Cover that may be used to anchor the Leads.
The non‑implantable components of the Boston Scientic DBS System include the following:
• An External Trial Stimulator (ETS) and OR Cables that may be used for intraoperative
testing.
• A Clinician Programmer (CP) that is used to set and adjust stimulation parameters.
-A Pairing Magnet is used to facilitate rst‑time pairing between a Vercise Genus
IPG and CP and/or Remote Control.
-A Programming Wand is used to connect the CP to Vercise Gevia and
Vercise PC IPGs.
• A Tunneling Tool that is used to create a subcutaneous tunnel for the Leads and
Lead Extensions.
• External patient devices, such as the Remote Control that is used to communicate with
the IPG, and a Charging System to recharge the battery of rechargeable IPGs.
-The Charging System is only applicable for rechargeable IPGs.
Note: The DBS System components were not made with natural latex.
Intended Use / Indications for Use
The Boston Scientic DBS System is indicated for use in bilateral stimulation of the subthalamic
nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to
advanced levodopa‑responsive Parkinson’s Disease (PD) that are not adequately controlled with
medication.

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Safety Information
Contraindications
The Boston Scientic DBS System, or any of its components, is contraindicated for the following:
Diathermy: Shortwave, microwave, and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Boston Scientic DBS System, or any of the system components.
The energy generated by diathermy can be transferred to the Boston Scientic DBS System,
causing tissue damage at the contact site resulting in severe injury or death.
Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation
(TMS): The safety of these therapies in patients implanted with the Boston Scientic DBS System
has not been established. It is possible that the energy generated by these therapies can be
transferred to the Boston Scientic DBS System, causing tissue damage that may result in severe
patient injury or death.
Magnetic Resonance Imaging (MRI) (Vercise PC Only): Patients implanted with
the full Vercise PC DBS System (DBS Leads, Lead Extensions, and Stimulator) should not be
subjected to MRI. MRI exposure may result in the following:
• Dislodgement of implanted components.
• Heating of the Contacts or other system components, causing permanent tissue
lesioning.
• Damage to the Stimulator’s electronics.
• Current induction through the DBS Leads and Vercise PC DBS System causing
unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or death.
Note: The Vercise DBS Lead‑Only System (before Stimulator is implanted), the Vercise Gevia
System, and the Vercise Genus System are MR Conditional. An MRI examination can be
conducted safely when all the instructions in the supplemental manual ImageReady™ MRI
Guidelines for Boston Scientic DBS Systems are followed.
For the latest version of the manual, go to http://www.bostonscientic.com/manuals.
Patient Incapability: Patients who are unable to properly operate the Remote Control
and Charging System (when applicable) should not be implanted with the Boston Scientic
DBS System.
Poor Surgical Candidates: The Boston Scientic DBS System is not recommended for
patients who are poor surgical candidates.
Unsuccessful Test Stimulation: The Boston Scientic DBS System should not be used in
patients who experience unsuccessful test stimulation.

Safety Information
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Warnings
Automobiles and Equipment: Patients should operate automobiles, other motorized
vehicles, or potentially dangerous machinery/equipment with caution after receiving the Boston
Scientic DBS System. Patients should avoid performing activities that would be dangerous if
treated symptoms were to return, or in which stimulation changes could occur.
Charge Density: High levels of stimulation may damage brain tissue. To maintain safe limits,
the DBS programming software will display a message when the stimulation level selected would
exceed the safe limit, and programming of these settings will be prevented.
Patients may be granted the ability to change stimulation amplitude with the Remote Control within
clinician‑dened limits. The software prevents patient‑controlled amplitude from exceeding the limit.
DBS Extension Connector: Implanting the DBS Lead Extension Connector in the soft
tissue of the neck may increase the chance of DBS Lead breakage. Boston Scientic recommends
placing the DBS Lead Extension Connector behind the ear such that glasses or headgear do not
interfere with the implanted DBS System.
Electromagnetic Interference: Strong electromagnetic elds can potentially turn
stimulation off, cause temporary unpredictable changes in stimulation, or interfere with
Remote Control communication. If an electromagnetic eld is strong enough to turn stimulation off,
this will be temporary and stimulation may automatically return once the electromagnetic eld is
removed. Patients should be advised to avoid or exercise care around the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department
stores, libraries, and other public establishments. Patients should proceed with caution,
ensuring that they move through the center of the detector as quickly as possible.
Interference from these devices should not cause damage to the implanted device.
• Security screeners, such as those used in Airport Security or at entrances to government
buildings, including hand‑held scanners. Patients should request assistance to bypass
the security screener and advise the security staff that they have an implanted medical
device. If patients must pass through the security screener, they should move through
the security screener quickly and stay as far as allowed from the screener. Interference
from these devices should not cause damage to the implanted device.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft
systems that can broadcast a radio frequency (RF) signal. The high energy elds
produced by these systems may interfere with the operation of the Remote Control and
its ability to control stimulation.
• For DBS devices not using Bluetooth technology for communication, other sources of
electromagnetic disturbance, such as RF transmitters at television or radio broadcast
stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service
band transceivers.

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• For DBS devices using Bluetooth technology for communication, other sources of
electromagnetic disturbance, such as Wi‑Fi routers, cordless phones, Bluetooth wireless
streaming devices, baby monitors, and microwave ovens.
Note: When in close proximity to them, equipment that generates strong electromagnetic elds
might cause unintended stimulation or interfere with wireless communication even if they
comply with International Special Committee on Radio Interference (CISPR) requirements.
Heat Due to Charging: Patients should not charge while sleeping. This may result in a burn.
The Charger may become warm while charging the Stimulator. The Charger should be handled
with care. Failure to use the Charging Collar, Charging Belt, or an Adhesive Patch while charging,
as directed, may result in a burn. If the patient experiences pain or discomfort, they should stop
charging and contact their healthcare provider.
Intracranial Hemorrhage: Special precautions should be taken for patients who are prone
to hemorrhage, including patients with coagulopathy, high blood pressure, or those who are using
prescribed anticoagulants. Microelectrode penetration and DBS Lead insertion can put patients
who have a likelihood of intracranial hemorrhages at greater risk.
Magnetic Resonance Imaging (MRI): The Vercise Genus and Vercise Gevia
DBS Systems are “MR Conditional.” This means that an MRI examination can be conducted safely
using a 1.5 Tesla horizontal closed bore MRI system when all instructions and safety information in
the supplemental manual ImageReady™ MRI Guidelines for Boston Scientic DBS Systems are
followed.
The ImageReady™ MRI Guidelines for Boston Scientic DBS Systems manual appears on the
Boston Scientic website www.bostonscientic.com/manuals or may be provided in your region. It
is important to read the information in this supplemental manual in its entirety before conducting or
recommending an MRI examination on a patient with a Boston Scientic DBS System.
External Devices: The external/non‑implantable components of the Boston Scientic DBS System
(External Trial Stimulator, ETS Adapter, OR Cables, Remote Control, Charging System,
Clinician Programmer, and accessories) are MR Unsafe. They must not be taken into any MR
environment such as the MRI scanner room.
Other Active Implantable Devices: Concurrent use of Stimulators such as the
Boston Scientic DBS Stimulator and other active implantable devices, such as pacemakers,
cardioverter debrillators, or medication delivery pumps may result in interference with the
operation of the devices. If the patient requires concomitant implantable active devices, careful
programming of each system is necessary.
Pregnancy: It is unknown whether this device may cause complications with pregnancy and/or
hurt an unborn baby.
Stimulator Damage: Chemical burns may result if the Stimulator housing is ruptured or
pierced, exposing the patient’s tissue to battery chemicals. Do not implant the Stimulator if the
housing is damaged.

Safety Information
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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
benets 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.
Therapeutic Ultrasound: Implanted components of the Boston Scientic DBS System
should not be exposed to therapeutic levels of ultrasound energy. The implanted device may
concentrate the ultrasound eld and may cause patient harm.
Unauthorized Modication: Unauthorized modication to the medical devices is prohibited.
The integrity of the DBS System could be compromised and harm or injury to the patient could
occur.

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Precautions
Physician training is required for usage of the Boston Scientic DBS System. The implanting
physician should be experienced in the subspecialty of Stereotactic and Functional Neurosurgery.
The following is a list of precautions that should be taken when implanting or using the DBS
Stimulator.
Cell Phones: While interference caused by cell phones is not anticipated, the full effects of
interaction with cell phones are unknown at this time. Patients should be instructed to avoid placing
cell phones directly over the implanted Stimulator. If interference does occur, move the cell phone
away from the implanted Stimulator or turn off the cell phone.
Cleaning the Charging Belt or Charging Collar: Do not machine wash the Charging
Belt or Charging Collar.
Cleaning the Remote Control, External Trial Stimulator, Charger,
Base Station, Power Supply, and Programming Wand: Do not use abrasive
cleansers for cleaning. Do not clean any of the accessories while they are directly or indirectly
connected to a power outlet.
As an operator of the external devices, perform only the following maintenance tasks on the
external devices:
• Changing the battery
• Charging the battery
• Cleaning
Ensure that the devices are not in use while performing service and maintenance tasks.
Component Removal, Disposal, and Return: Any explanted components should be
returned to Boston Scientic. The Stimulator should be explanted in the case of cremation and
returned to Boston Scientic. Cremation may cause the Stimulator battery to explode.
The Remote Control or Charger should not be disposed of in re, as these devices contain
batteries which may explode causing injury when exposed to re. Used batteries should be
disposed of in accordance with local laws and regulations.
Dispose of non‑implantable components and packaging in accordance with hospital, administrative,
and/or local government policy.
Components: The use of components other than those approved and/or supplied by
Boston Scientic and intended for use with the Boston Scientic DBS System may damage the
DBS System, diminish the effectiveness of therapy, and/or put the patient at unknown risk.
Connections: Before inserting any DBS Lead or DBS Lead Extension into any Connector
or Header ports, including the Stimulator Header, DBS Lead Extension Connectors, and
OR Cable Assembly, always wipe the DBS Lead with a sterile, dry cotton sponge. Contamination
inside the Connector or Header ports may be difcult to remove and can cause high impedances,
preventing electrical connectivity which may compromise the integrity of the stimulation circuit.

Safety Information
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Device Failure: Implants can fail at any time due to random component failure, loss of battery
functionality, or DBS Lead breakage. Stopping brain stimulation suddenly can cause serious
reactions to develop. If the Stimulator stops working, patients should be instructed to turn off the
Stimulator and contact their healthcare provider immediately so that the system can be evaluated
and appropriate medical care can be given to manage the return of symptoms.
Environmental Precautions: Patients should avoid activities that could potentially involve
large amounts of electromagnetic interference. Devices that contain permanent magnets, such as
speakers, should not be placed near the Stimulator because they may cause the DBS System to
turn on or off.
Excess DBS Extension: Coil excess DBS Lead Extension around or below the Stimulator.
Excess wire on top of the Stimulator may increase the potential for communication interference,
tissue erosion, or damage during Stimulator replacement surgery.
Inspect Packaging Before Use: Check the expiration date on the package before opening
the sterile package and using the contents. Do not use the contents if the current date is past the
expiration date, if the package is opened or damaged, or if contamination is suspected because of
a defective sterile package seal.
• Inspect the seal integrity of the outer tray before use.
• Open the inner tray in the sterile eld.
• If the Stimulator was dropped, do not implant it in a patient. The dropped Stimulator
may have lost sterility, experienced a loss of hermeticity, or been otherwise damaged.
Replace the dropped Stimulator with a new, sterile Stimulator prior to implantation.
Return the damaged Stimulator to Boston Scientic.
• Do not use any component that shows signs of damage.
• Do not use if “Use By” date has expired.
Massage Therapy: Patients should avoid receiving massage therapy near the implanted
system components. If a patient does receive massage therapy, the patient should inform
the masseuse that they have an implanted device and show him/her where the Stimulator,
DBS Lead Extensions, and DBS Leads are located. The patient should advise the masseuse to
avoid these areas and proceed with caution.

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Medical Devices/Therapies: The following medical therapies or procedures may turn
stimulation off, cause permanent damage to the Stimulator, or may cause injury to the patient.
If any of the procedures below is required by medical necessity, the procedure(s) should be
performed as far from the implanted components as possible. Stimulator function should be
conrmed after the procedure. Ultimately, however, the Stimulator may require explantation
because of damage to the device or patient harm.
• Diagnostic ultrasonic scanning is unlikely to damage the Stimulator if stimulation is
turned off. Testing has been completed to applicable standards.
• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads
and/or Stimulator. See additional instructions below. Bipolar or monopolar electrocautery
may be used. Electrocautery probes must be kept a minimum of 1 inch away from the
implanted device.
• External Debrillation – Safe usage of external debrillation has not been established
in DBS patients. Debrillation of the patient is unlikely to permanently damage the
implanted device if stimulation is turned off and the debrillator electrode does not come
into contact with any component of the implantable device. Testing has been completed
to applicable standards.
• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry.
See additional instructions below.
• Radiation Therapy – Lead shielding should be used over the Stimulator to prevent
damage from high radiation. Any damage to the device by radiation may not be
immediately detectable.
• X-ray and CT scans may damage the Stimulator if stimulation is on. X-ray and CT scans
are unlikely to damage the Stimulator if stimulation is turned off.
If the patient is required to undergo lithotripsy, electrocautery, external debrillation, radiation
energy, ultrasonic scanning, X‑ray, or CT scan, observe the following:
• Turn off stimulation at least ve minutes before the procedure application.
• All equipment, including probes, ground plates and paddles, must be used as far away
from the Stimulator as possible and oriented such that energy is not directed through or
across the Stimulator, Leads, or Lead Extensions.
• Every effort should be taken to keep elds, including current, radiation, or high‑output
ultrasonic beams, away from the Stimulator.
• Equipment should be set to the lowest energy setting clinically indicated.
• Conrm the system is functioning properly following the procedure. Turn stimulation on
and observe for the return of therapy to conrm functionality.

Safety Information
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Operating Temperature: The operating temperature of the External Trial Stimulator, Remote
Control, and Programming Wand is 5 °C to 40 °C (41 °F to 104 °F). For proper operation, do not
use the Charging System if the ambient temperature is above 35 °C (95 °F).
Other Models of External Devices: Only the Remote Control, Charging System
(as applicable), and Clinician Programmer that were provided with the Boston Scientic
DBS System should be used with the Boston Scientic DBS System. Other models of these
devices will not function with the Boston Scientic DBS System.
Patient Activities: During the two weeks following surgery, it is important for the patient to
exercise extreme care so that appropriate healing will secure the implanted components. During
this period, the patient should not attempt to move heavy objects. Instruct the patient to restrict
head movements, including extension or exion of the neck and rotation of the head, until healing
is complete.
Setscrews: Before tightening Setscrews, always test impedance to conrm electrical
connectivity. Tightening a Setscrew onto a Lead Contact may damage the Contact and may result
in the need to replace the DBS Lead or DBS Lead Extension.
Single Use Only, Do Not Resterilize: For single patient use only. Do not reuse, reprocess
or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of
the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or
death of the patient.
Sterilization: Contents of the surgical kits are supplied sterile using an ethylene oxide process.
Do not use if sterile barrier is damaged. If damage is found, call Boston Scientic Technical Support
and return the damaged part to Boston Scientic.

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Stimulator Orientation: Orient the Stimulator parallel to the skin surface. Suboptimal
placement of the Stimulator may result in a revision surgery. Patients should avoid touching
the Stimulator site or incisions. If patients notice a change in the appearance of the skin at the
Stimulator location, such as the skin becoming thin over time, they should contact their healthcare
provider.
In order to ensure effective device communications, including device programming, and proper
charging, perform the following:
• For rechargeable IPGs, orient the Stimulator parallel to the skin surface and at a depth
less than 2 cm and greater than 0.5 cm below the skin.
• For non-rechargeable Vercise Genus IPGs, orient the Stimulator parallel to the skin
surface and at a depth less than 2.5 cm below the skin to ensure effective device
communication.
• For the non‑rechargeable Vercise PC IPG (DB‑1140‑S), orient the Stimulator parallel to
the skin surface. There is no depth restriction for the Vercise PC IPG.
• The etched writing “This Side Up” must be facing out of the pocket toward the patient’s
skin.
Suboptimal placement of the Stimulator may result in the inability to communicate with the device
or inability to recharge and may require a revision surgery.
Patients should be instructed not to change the orientation of or turn over the Stimulator. If the
Stimulator ips over in the body, then it cannot communicate or be charged. If stimulation cannot
be turned on after charging, the Stimulator may have changed orientation or rotated; patients
should contact their healthcare provider to arrange an evaluation of the system.

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Storage, Handling, and Transport: Store implanted components, such as the Stimulator,
Leads, and Lead Extensions, between 0 °C to 45 °C (32 °F to 113 °F) in an area where they
are not exposed to liquids or excessive moisture. Temperatures outside of the stated range can
cause damage. If stored in conditions beyond the required storage temperature, do not use the
components and return to Boston Scientic.
The non‑rechargeable Stimulator will enter storage mode if its temperature falls below 5 °C. When
the Stimulator is in storage mode, it will not connect to a Remote Control or Clinician Programmer.
To exit storage mode, increase the Stimulator temperature above 8 °C.
Store external components like the Remote Control, External Trial Stimulator, ETS Adapter,
OR Cable and Extension (DB‑4100‑A and SC‑4100‑A), and Charging System between
‑20 °C to 60 °C (‑4 °F to 140 °F). Store the Push‑Button OR Cables (DB‑4208 and DB‑4216)
between 0 °C to 45 °C (32 °F to 113 °F). Do not expose the external components to excessively
hot or cold conditions. Do not leave the devices in your car or outdoors for extended periods of
time. The sensitive electronics can be damaged by temperature extremes, particularly high heat.
Handle the system components and accessories with care. Do not drop them or submerge
them in water. Avoid all sources of water that could come into contact with the devices. Although
reliability testing has been performed to ensure quality manufacturing and performance, dropping
the devices on hard surfaces or in water, or other rough handling, can permanently damage the
components. Keep the Remote Control and Charger away from pets, pests, and children to avoid
damage to the devices.
Care must be taken to avoid damaging the DBS Lead with sharp instruments or excessive force
during surgery. The following guidelines will help to ensure the longevity of components:
• Do not sharply bend or kink the DBS Lead or Lead Extension.
• Do not tie Suture(s) directly to the DBS Lead or Lead Extension body.
• Avoid pulling an implanted DBS Lead taut; stress relief loops may help to minimize
tension on the DBS Lead.
• Avoid handling the DBS Lead with sharp instruments; use only rubber‑tipped forceps.
• Take care when using sharp instruments, such as hemostats or scalpels, to prevent
damaging the DBS Lead.
Surgical Tape: If tape is used to temporarily secure the DBS Lead during surgery, caution
should be used to ensure the Lead is not cut or damaged when removing the tape.
Sutures: Do not apply Sutures tightly around the DBS Leads, as this may damage the insulation
of the DBS Lead and may result in DBS Lead failure.
Tissue Reaction: Temporarily, there may be some pain in the area of the Stimulator as the
incisions heal. If there is excessive redness around the wound area, it should be checked for
infection. In rare cases, adverse tissue reaction to implanted materials can occur.

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Adverse Events
The following is a list of known risks with the use of deep brain stimulation. There may be risks that
are unknown. Note that some of these symptoms may be resolved or reduced by current steering,
changing stimulation parameters, or by changing the position of the Lead during surgery.
If any of these events occur, patients should inform their healthcare provider as soon as possible.
Risks Associated With Surgical Procedure and Post‑Operative Period
• Allergic reaction to anesthesia or antibiotics including anaphylaxis
• Blood clot formation in the extremities (e.g., in the veins of the legs)
• Blood clot or air forming in or traveling through the blood stream, which can block blood
ow to parts of the lungs or other tissue that could be life‑threatening
• Brain contusion (bruising)
• Brain or cerebral spinal uid (CSF) uid infection or inammation
• CSF leaking outside the skull or collecting inside the skull abnormally
• Confusion or problems with attention, thinking, or memory (acute or chronic)
• Death
• Fibrosis (thickened skin and scarring) around the Lead Extension (including tightening,
tethering, and bowstringing)
• Hemiparesis (muscular weakness or partial paralysis on one side of the body)
• Hemiballism (uncontrollable involuntary movements of a limb or limbs on one or both
sides of the body)
• Intracranial hemorrhage (which can lead to stroke, paralysis, or death)
• Intraparenchymal cyst
• Infection
• Injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the
brain
• Injury to the nerves in the armpit (brachial plexus) leading to pain or weakness of the
arm or hand
• Neurosurgery/anesthesia risks, including unsuccessful implant and pneumonia
• Pain at the surgical site(s), headache or discomfort
• Seizures
• Speech or language difculties
• Subcutaneous hemorrhage or seroma (blood or uid collection under the skin, including
the skin over the skull)
• Stroke resulting in temporary or permanent problems
• Swelling or bruising of the muscles or skin in the area of the Lead or of the IPG implant
Possible Side‑Effects of Stimulation
• Confusion or problems with attention, thinking, or memory
• Gait difculty (trouble walking) and falls
• New onset or worsening depression, which may be temporary or permanent, and
suicidal ideations, suicide attempts, and suicide

Safety Information
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• Pain, headache or discomfort
• Pneumonia from difculty with swallowing or from inhaling uid
• Psychiatric disturbances such as anxiety, depression, lessened interest or emotion,
hypersexuality, aggression, mania or hypomania, psychosis, emotional sensitivity, sleep
problems, suicide, or suicidal thoughts or attempts
• Seizures
• Sensory changes
• Speech or language problems
• Swallowing difculty
• Systemic effects such as rapid heart beat, sweating, fever, dizziness, changes in
kidney function, difculty passing urine, sexual effects, nausea, difculty having bowel
movements, bloating
• Weakness, muscle spasms, shaking, restlessness, or problems with movement
• Undesirable sensations (e.g., tingling)
• Visual problems, eyelid or eye movement difculties or other eye‑related symptoms
• Weight changes
Device‑Related Risks
• Allergic or immune system response to implanted materials
• Failure or malfunction of any part of the device, including but not limited to: Battery
leakage, battery failure, Lead or Extension breakage, hardware malfunctions, loose
connections, electrical shorts or open circuits, and Lead insulation breaches, whether or
not these problems require device removal and/or replacement
• Implant site complications such as pain, poor healing, redness, warmth, swelling or
wound reopening
• Implanted device components (Stimulator, Lead, or Extension) may move from original
implanted location or wear through the skin, which may lead to the need for additional
surgery
• Infection
• Interference from external electromagnetic sources
• Loss of adequate stimulation
• Pain, headache or discomfort
• Skin irritation or burns at the Stimulator site
• Stiffness in muscles or joints
• Worsening of disease symptoms, potentially caused by loss of stimulation, medication
changes, surgery, or illness. In rare cases worsening can become a life‑threatening crisis
associated with varied symptoms such as mental status changes, fever, and muscle
rigidity
• Swelling, including uid collecting around the device

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Service and Maintenance
External Trial Stimulator (ETS) Maintenance
The ETS may be used to conduct intraoperative stimulation testing during the Lead implantation
procedure. Refer to the DFU listed in your DBS Reference Guide for detailed procedure and
guidelines for intraoperative testing.
1. Left Connector
2. Right Connector
3. Stimulator Light
4. Stimulation ON/OFF
5. Battery Indicator Light
Figure 1. External Trial Stimulator
To turn stimulation on and off on the ETS, press and release the ON/OFF button on the ETS
(Figure 1). When the stimulation is on, the Stim Indicator Light will blink green. The ETS runs on
two AA batteries that are provided with every ETS kit. When the batteries need replacement, the
Battery Indicator Light will change from a ashing green to a ashing yellow.
Ensure that stimulation is off (the indicator light is not blinking) before opening the ETS battery
compartment.
To install new batteries in the ETS:
1. Conrm that stimulation is OFF by conrming that the stimulation indicator light is not blinking.
2. On the rear of the ETS, push in slightly and slide down the battery compartment cover.
3. Remove the old batteries.
4. Place two new AA batteries in the slots matching the positive (+) and negative (‑) markings in
the compartment.
5. Align the battery compartment cover on the case and slide the cover into position until is snaps
closed.
6. Both the Battery Indicator light and the Stim On indicator lights will emit an amber glow for
15 seconds after which the Battery Indicator light blinks green.

Service and Maintenance
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Cleaning the Charging System
The components of the Charging System (Charger, Base Station, and Power Supply) can be
cleaned using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy
detergents should be removed with a damp cloth. Do not use abrasive cleansers for cleaning. Do
not clean any of the accessories while they are directly or indirectly connected to a power outlet.
Hand wash the Charging Belt or Charging Collar with mild soap and warm water. Do not machine
wash the Charging Belt or Charging Collar. Let the Charging Belt or Charging Collar air dry. Be
sure to remove the Charger and Counterweight from the Charging Collar before washing the
Charging Collar. Be sure to remove the Charger from the Charging Belt before washing the
Charging Belt.
Cleaning the Remote Control
The components of the Remote Control can be cleaned using alcohol or a mild detergent applied
with a cloth or tissue. Residue from soapy detergents should be removed with a damp cloth. Do not
use abrasive cleansers for cleaning. Do not clean while directly or indirectly connected to a power
outlet.
Cleaning the Programming Wand
The components of the Programming Wand can be cleaned using alcohol or a mild detergent
applied with a cloth or tissue. Residue from soapy detergents should be removed with a damp
cloth. Do not use abrasive cleansers for cleaning. Do not clean while directly or indirectly
connected to a power outlet.

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Electromagnetic Compatibility
EN 60601‑1‑2 Classication Information
• Internally Powered Equipment
• Continuous Operation
• Ordinary Equipment
• Class II
Table 1: Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
The Boston Scientic DBS System is intended for use in electromagnetic environment specied below.
The customer or the user of the Boston Scientic DBS System should ensure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic Environment
– Guidance
RF emissions
CISPR 11 Group 1
The Boston Scientic DBS System
uses RF energy only for its internal
function. Therefore, its RF emissions
are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11 Class B The Boston Scientic DBS System is suitable for use in all establishments,
including domestic establishments
and those directly connected to the
public low voltage power supply
network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000‑3‑2 Class B
Voltage uctuations/ icker emissions
IEC 61000‑3‑3 Complies