Boston Scientific VERCISE Series User manual

Vercise™
Deep Brain Stimulation
System
Physician Manual
92215483-02
Content: 92215546 REV A
Vercise™ Deep Brain
Stimulation System
Physician Manual
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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.
Trademarks
All trademarks are the property of their respective holders.
Additional Information
For labeling symbols, see the Labeling Symbols DFU.
Product Model Numbers
Model Description
DB-1110-C Vercise IPG Kit
DB-2201-30AC DBS Lead Kit, 30cm
DB-2201-45BC DBS Lead Kit, 45cm
DB-2201-30DC DBS Lead Kit, 30cm
DB-2201-45DC DBS Lead Kit, 45cm
DB-2201-30EC DBS Lead Kit, 30cm
DB-2201-45EC DBS Lead Kit, 45cm
NM-3138-55 55 cm 8 Contact Extension Kit
DB-2500-C Vercise Physician’s Spare Kit
SC-4252 Tunneling Tool, 28 cm Straw
SC-4254 Tunneling Tool, 35cm Long
SC-4100A OR Cable & Extension
DB-5110-C Vercise ETS

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Table of Contents
Introduction.................................................................................................... 1
Overview of Manual ................................................................................................1
Intended Use / Indications for Use..........................................................................1
System Description ................................................................................................1
Safety Information......................................................................................... 2
Contraindications ...................................................................................................2
Warnings ...........................................................................................................3
Precautions ......................................................................................................6
Adverse Events ...............................................................................................11
Package Contents ....................................................................................... 13
Contents of the Implantable Pulse Generator Kit .................................................13
Contents of the Lead Kit .......................................................................................13
Contents of the Extension Kit ...............................................................................13
Contents of the Tunneling Tool Kit ........................................................................13
Contents of the Spares Kit....................................................................................14
Other Components ..............................................................................................14
DBS Lead Implantation ............................................................................... 15
Pre-Conditions ......................................................................................................16
Implanting the DBS Lead......................................................................................16
Intraoperative Stimulation Testing.........................................................................18
Securing the DBS Lead ........................................................................................20
Stimulator Implantation .............................................................................. 24
Exposing the DBS Lead........................................................................................24
Connecting the DBS Lead to the DBS Extension .................................................25
Assembling the Tunneling Tool ............................................................................27
Tunneling the DBS Lead and Extension...............................................................28
Connecting the Stimulator ....................................................................................30
Vercise™ DBS System Revisions & Explantation.................................... 34
Explanting the DBS Lead......................................................................................34
Explanting the DBS Extensions ............................................................................36
Explanting or Replacing the Stimulator.................................................................37
The Vercise™ Stimulator ........................................................................... 38
Stimulator Battery .................................................................................................39
Stimulator Battery Messages................................................................................39
The Charging System.................................................................................. 40
Charging the Charger ...........................................................................................41
Charging the Stimulator ........................................................................................41
Using the Charging Collar.....................................................................................41
Using the Adhesive Patch.....................................................................................43
Properly Aligning the Charger...............................................................................44
The Remote Control .................................................................................... 46
Basic Operation ....................................................................................................46
Remote Control Position.......................................................................................47
Stimulator Linking .................................................................................................47
Stimulation On/Off.................................................................................................49
Signal Strength .....................................................................................................49
Stimulation Amplitude ...........................................................................................50
Stimulator Battery ................................................................................................50
Program Selection ................................................................................................51
Modifying and Saving Programs...........................................................................52
Individual Area Amplitude .....................................................................................53

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Restore Option......................................................................................................53
Searching..............................................................................................................53
Clinician Options...................................................................................................54
Stimulation Guidelines................................................................................ 58
Charge Density .....................................................................................................58
Detailed Device Description ...................................................................... 59
General Component Description .........................................................................59
Stimulator Physical Characteristics ......................................................................60
Stimulator Programmable Characteristics ...........................................................61
DBS Lead .............................................................................................................62
DBS Extension......................................................................................................63
DBS Lead Boot .....................................................................................................64
Suture Sleeve .......................................................................................................65
Tunneling Tool.......................................................................................................66
Programmer Communication ...............................................................................67
Vercise™ DBS System Registration.......................................................... 68
Technical Support ...................................................................................... 69
Limited Warranty - Stimulator ................................................................... 72
Limited Warranty - Leads ........................................................................... 74
Limited Warranty - Externals...................................................................... 75
Appendix ..................................................................................................... 76
Rechargeable Stimulator Battery Longevity .........................................................76

Introduction
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Introduction
Overview of Manual
This manual describes the implantation and usage of the Vercise™ Deep Brain
Stimulation (DBS) System. The Vercise DBS System features a Stimulator coupled
with DBS Leads and DBS Extensions. In this manual you will also nd detailed
descriptions of each system component. Additional information about programming
the Vercise DBS System programming can be found in the DBS Programming
Manual.
Intended Use / Indications for Use
The Vercise Deep Brain Stimulation System is indicated for use in the following:
• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal
globus pallidus (GPi) for treatment of levodopa-responsive Parkinson’s
disease which is not adequately controlled with medication.
• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal
globus pallidus (GPi) for treatment of intractable primary and secondary
dystonia, for persons 7 years of age and older.
• Thalamic stimulation for the suppression of tremor not adequately controlled
by medications in patients diagnosed with Essential Tremor or Parkinson’s
disease.
• Unilateral or bilateral stimulation of the post-commissural fornix in the
treatment of patients 65 years and older with mild probable Alzheimer’s
disease, as an adjunctive therapy for patients on a stable dose of cholinesterase
inhibitor medication.
System Description
The Vercise DBS System includes a Stimulator with DBS Leads for unilateral or
bilateral stimulation. There are also DBS Extensions that allow the DBS Leads
mounted in the skull to be extended to reach the Stimulator implanted near the
clavicle.
The rechargeable Vercise DBS System utilizes current steering across eight contacts
per DBS Lead to provide precise positioning of stimulation. The Stimulator is
controlled by a handheld Remote Control, and can be interfaced with a Clinician’s
Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator
battery must be replenished with an RF charging device provided in the Patient DBS
Charging Kit.
Note: This product was not made with natural latex.

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Safety Information
Contraindications
The Boston Scientic Vercise™ DBS System, or any of its components,
is contraindicated for:
Diathermy. Shortwave, microwave, and/or therapeutic ultrasound diathermy.
The energy generated by diathermy can be transferred to the Vercise DBS System,
causing tissue damage at the contact site resulting in severe patient injury or death.
Magnetic Resonance Imaging (MRI). Patients implanted with the full Vercise
DBS System (leads, extensions and stimulator) should not be subjected to MRI. MRI
exposure may result in:
• 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 DBS System causing
unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or even death.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR
conditional. An MRI examination can be conducted safely when all
instructions in the supplemental manual MRI Guidelines for Boston Scientic
DBS Systems are followed.
For the latest version of the manual go to www.bostonscientic.com/manuals.
Patient Incapability. Patients who are unable to properly operate the Remote
Control and Charging System should not be implanted with the Vercise DBS System.
Poor Surgical Risks. The Vercise DBS System is not recommended for patients
who are poor surgical risks.

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Warnings
Unauthorized Modication. Unauthorized modication to the medical devices is
prohibited. System integrity could be compromised and harm or injury to the patient
could occur if the medical devices are subjected to unauthorized modication.
Intracranial Hemorrhage. Special precautions should be taken for patients who
are prone to hemorrhage including patients with coagulopathy, with high blood
pressure, or who are using prescribed anticoagulants. Microelectrode penetration
and DBS Lead insertion can put patients who have a likelihood of intracranial
hemorrhages at greater risk.
Charge Density. High levels of stimulation may damage brain tissue. Whenever
possible, the current amplitude and pulse width should be programmed such that the
charge density is below 30 µC/cm2 per stimulation phase. To maintain safety limits,
the software will display a warning when the level of stimulation exceeds 30 µC/cm2
per stimulation phase; however, the software allows the stimulation to be adjusted
above this level by the physician.
Patients may have the ability to change the amplitude with the Remote Control.
Set and verify the maximum and minimum amplitude levels allowed by the Remote
Control to ensure that current levels remain safe.
Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should
not be used on patients implanted with the Vercise™ DBS System, or any of the
system components. The Stimulator, whether it is turned on or off, may be critically
damaged by the use of diathermy. The energy generated by diathermy can be
transferred to the Vercise™ DBS System, causing tissue damage at the contact site
resulting in severe injury or death.
Magnetic Resonance Imaging. Patients implanted with the full Vercise DBS
System (leads, extensions and stimulator) should not be subjected to Magnetic
Resonance Imaging (MRI). MRI exposure may result in:
• 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 DBS System
components causing unpredictable levels of stimulation.
• Distortion of the diagnostic image.
• Personal injury or even death.

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Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR
conditional. An MRI examination can be conducted safely when all
instructions in the supplemental manual MRI Guidelines for Boston Scientic
DBS Systems are followed.
For the latest version of the manual go to www.bostonscientic.com/manuals.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn
the Stimulator off, cause temporary unpredictable changes in stimulation, or interfere
with the Remote Control communication. Patients should be counseled to avoid or
exercise care around:
• Theft detectors such as those used at entrances/exits of department stores,
libraries, and other public establishments. The patient should proceed with
caution, ensuring to move through the center of the detector as quickly as
possible.
• Security screeners, such as those used in Airport Security or at entrances
to government buildings, including hand-held scanners. The patient should
request assistance to bypass the device. If the patient must pass through the
security screener, they should move quickly through the device staying as far
from the physical device as allowable.
• 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.
• Other sources of electromagnetic interference, such as RF transmitters at
television or radio broadcast stations, Amateur Radio or Citizens Band radio
transceivers, or Family Radio Service band transceivers.
DBS Extension Connector and Stimulator Placement. Implanting the DBS
Extension connector in the soft tissue of the neck may increase the chance of DBS
Lead breakage. Boston Scientic recommends placing the DBS Extension connector
behind the ear such that glasses or headgear do not interfere with the system.
Boston Scientic recommends that the Stimulator be placed subclavicularly.
Heat Due to Charging. The Charger may become warm while charging the
Stimulator. The Charger should be handled with care. Failure to use either the
Charging Collar or an Adhesive Patch while charging, as directed, may result in
a burn. The Patient should not charge while sleeping. This may result in a burn. If the
patient experiences pain or discomfort, they should cease charging and contact their
physician.

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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.
Suicide. Depression, suicidal ideation, and suicide are known risks of DBS.
Consider adjustment of stimulation, discontinuing stimulation, adjusting medication,
and/or psychiatric referral.
Other Active Implantable Devices. Stimulators, such as the Vercise™
Stimulator, may interfere with the operation of implanted sensing stimulation devices
such as pacemakers or cardioverter debrillators. The effects of implanted stimulation
devices on neurostimulators, such as the Vercise DBS System, are unknown.
Automobiles and Equipment. Patients should operate automobiles, other
motorized vehicles, or potentially dangerous machinery/equipment with caution after
receiving the Vercise DBS System. Performing activities that would be dangerous if
treated symptoms were to return, or instances in which stimulation changes occur,
should be avoided.
Pregnancy
It is unknown whether this device may cause complications with pregnancy and/or
hurt an unborn baby.

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Precautions
Physician training is required for usage of the Vercise™ 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.
Connections. Before inserting any DBS Lead or DBS Extension into any connector
or header ports, including the Stimulator header, DBS Extension connectors, and
operating room cable assembly, always wipe the DBS Lead with a dry cotton sponge.
Contamination inside the ports may be difcult to remove and can cause high
impedances, preventing electrical connectivity which may compromise the integrity
of the stimulation circuit.
Components. The use of components other than those supplied by Boston
Scientic and intended for use with the Vercise DBS System may: damage the
system, diminish the effectiveness of therapy, and/or put the patient at unknown risk.
Excess DBS Extension. Coil excess DBS Extension around or below the
Stimulator. Excess wire on top of the Stimulator may increase the potential for tissue
erosion or damage during Stimulator replacement surgery and may interfere with
charging.
Other Models of External Devices. Only the Remote Control, Clinician
Programmer, and Charger that were provided with the Boston Scientic Vercise™
DBS System should be used with the Vercise DBS System. Other models of these
devices will not function with the Vercise DBS System.
Stimulator Orientation. To ensure proper charging, orient the Stimulator
parallel to the skin surface and at a depth less than 2 cm below the skin. The etched
writing “This Side Up” must be facing out of the pocket towards the patients skin.
Suboptimal placement of the Stimulator may result in the inability to recharge and/or
a revision surgery.
Never attempt to change the orientation of or turn over the Stimulator. Patients should
avoid touching the Stimulator site or incisions. If the Stimulator ips over in the
body, then it cannot be charged. If stimulation cannot be turned on after charging,
the Stimulator may have changed orientation or rotated; patients should contact their
physician to arrange an evaluation of the system.
If a patient notices a change in appearance of the skin at the Stimulator location, such
as the skin becoming thin over time, they should contact their physician.
Setscrews. Before tightening Setscrews, always test impedance to conrm
electrical connectivity. Tightening a Setscrew onto a contact may damage the contact
and may result in the need to replace the DBS Lead or DBS Extension.

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Sutures. Do not apply sutures tightly around the DBS Leads, as this may damage
the DBS Leads’ insulation and may result in DBS Lead failure.
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.
Device Failure. Implants can fail at any time due to random component failure, loss
of battery functionality, or DBS Lead breakage. Suddenly stopping brain stimulation
can cause serious reactions to develop. If the Stimulator stops working even after
complete charging (up to four hours when properly aligned), patients should be
instructed to turn off the Stimulator and contact their physician immediately so that
the system can be evaluated and appropriate medical care given to manage the return
of symptoms.
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.
Cell Phones. While interference with 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 the cell phone directly over the Implanted Stimulator. If interference
does occur, move the cell phone away from the Implanted Stimulator or turn off the
phone.
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.
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 Extension, and DBS Leads are located. The patient should
have the masseuse avoid these areas and proceed with caution.
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 system to turn on or off.

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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:
• Electrocautery – Electrocautery can transfer destructive current into the
DBS Leads and/or Stimulator.
• External Debrillation – Safe usage of external debrillation has not been
established and damage should be ascertained following debrillation.
• Lithotripsy – High frequency signals directed near the Stimulator may damage
circuitry.
• 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.
• Transcranial Stimulation – Safe use of electromagnetic therapies, such as
transcranial magnetic stimulation, have not been established.
• MRI – Patients implanted with the full Vercise DBS System (leads, extensions
and stimulator) should not be subjected to MRI to avoid damage to the device
and patient harm.
Note: Vercise DBS Lead-only system (before Stimulator is implanted) is MR
conditional. An MRI examination can be conducted safely when all
instructions in the supplemental manual MRI Guidelines for Boston Scientic
DBS Systems are followed.
For the latest version of the manual go to www.bostonscientic.com/manuals.
• Diathermy – The energy generated by diathermy can be transferred to the
Vercise™ DBS System and may result of damage to the device or patient
harm.
If any of the above is required by medical necessity, the procedure(s) should be
performed as far from the implanted components as possible. Ultimately, however,
the Stimulator may require explantation as a result of damage to the device or patient
harm.
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 your
Boston Scientic representative and return the damaged part to Boston Scientic.
Resterilization. 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. If resterilization is desired, obtain a new sterile device for implantation.

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After use, return the Stimulator, DBS Leads, and DBS Extensions to Boston
Scientic and dispose of other components and packaging in accordance with
hospital, administrative and/or local government policy.
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.
• Inspect the seal integrity and sterile indicator on the inner tray. The sterile
indicator will be green with red stripes if sterile. Yellow stripes indicate the
tray is not sterile. If the tray is not sterile, do not use the components and
return to Boston Scientic.
• 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.
Operating Temperature. The operating temperature of the ETS and Remote
Control is 5–40 °C (41–104 °F). For proper operation, do not use the Charger if the
ambient temperature is above 35 °C (95 °F).
Storage, Handling and Transport. Store implanted components like Stimulators,
Leads, and 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.
Do not expose the Remote Control or Charging System 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. If the Remote Control or the Charging System is to be stored
for a period of time, be careful that the storage temperature does not exceed -20–60°
C (-4–140° F).
Handle the system components and accessories with care. Do not drop them or
submerge them in water. Accessories, including the Remote Control and Charger,
must be kept dry and not exposed to moisture. Although reliability testing has been
performed to ensure quality manufacturing and performance, dropping the devices

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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 Extension.
• Do not tie suture(s) directly to the DBS Lead or 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.
Component Removal & Disposal. 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 Charging System should not be disposed of in re, as these
components contain batteries which may explode causing injury when exposed
to re. Used batteries should be disposed of in accordance with local laws and
regulations.
Cleaning the Charging Collar. Hand wash the Charging Collar with mild soap
and warm water. Do not machine wash the charging collar. Let the Charging Collar
air dry. Be sure to remove the Charger and Counterweight from the Charging Collar
before washing the Charging Collar.
Cleaning the Remote Control, Charger, Base Station, & Power Supply.
The components 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 the Charger, Base Station,
or Power Supply while they are directly or indirectly connected to a power outlet.

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Adverse Events
The following is a list of known risks with the use of deep brain stimulation.
Specic adverse events may be more relevant depending on the indication and site
of stimulation. Not all risks are known. Note that some of these symptoms may be
resolved or reduced by current steering, changing stimulation parameters, or by
changing the position of the DBS Lead during surgery.
If any of these events occur, patients should contact their physician as soon as
possible to inform them.
• Allergic or immune system response
• Anesthesia/neurosurgery risks, including unsuccessful implant, exposure to
bloodborne pathogens
• CSF leak
• Death, including suicide
• Embolism, including air embolism and pulmonary embolism
• Failure or malfunction of any of the device components or the battery,
including but not limited to lead or extension breakage, hardware
malfunctions, loose connections, electrical shorts or open circuits and lead
insulation breaches, whether or not this requires explant and/or reimplantion
• Hemorrhagic or ischemic stroke, immediate or delayed, which could result
in temporary or permanent neurologic decits such as muscle weakness,
paralysis or aphasia
• Implant site complications such as pain, poor healing, wound reopening
• Infection
• Injury to tissues adjacent to implant or within surgical eld, such as blood
vessels, peripheral nerves, brain (including pneumocephalus), or pleura
(including pneumothorax).
• Interference from external electromagnetic sources
• Lead, extension (including extension header) and neurostimulator erosion or
migration
• Loss of adequate stimulation
• Mentation impairment such as attention or cognitive decits, memory
disturbances, or confusion
• Psychiatric disturbances such as anxiety, depression, apathy, mania, insomnia,
suicide, or suicidal ideation or attempts
• Motor problems such as paresis, weakness, incoordination, restlessness,
muscle spasms, postural and gait disorders, tremor, dystonia, or dyskinesias,
and falls or injuries resulting from these problems
• Musculoskeletal stiffness
• Neuroleptic malignant syndrome or acute akinesia can occur very rarely
• Overstimulation or undesirable sensations, such as paresthesia, transient or
persistent

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• Pain, headache or discomfort, transient or persistent, including symptoms due
to neurostimulation
• Poor initial lead location
• Radiation exposure due to imaging (CT, uoroscopy x-ray)
• Seizures
• Sensory changes
• Seroma, edema or hematoma
• Skin irritation or burns at neurostimulator site
• Speech or swallowing problems such as dysphasia, dysarthria or dysphagia, as
well as complications of dysphagia such as aspiration pneumonia
• Systemic symptoms-autonomic (tachycardia, sweating, increased blood
pressure, ushing, fever, dizziness), changes in renal function, urinary
retention, sexual effects, gastrointestinal (nausea, bowel retention, bloating)
• Thrombosis
• Undesirable sensations such as tingling or generalized warming
• Visual disturbances or periorbital symptoms, such as diplopia, eyelid
movement difculty, oculomotor difculties, transient ashes of light or other
visual eld effects
• Vivid memories
• Weight changes

Package Contents
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Package Contents
Contents of the Implantable Pulse Generator Kit
• Stimulator
• Stimulator Template
• Stimulator Header Plugs (2)
• Torque Wrench
Note: All contents of the inner package (or tray) are sterile.
Contents of the Lead Kit
(30 cm and 45 cm)
• DBS Lead with preloaded Straight Stylet
• Torque Wrench
• Lead Boot
• Lead Stop – Screw and Ring
• 1 cm Suture Sleeve
• 1 cm Split Suture Sleeve
• 2.3 cm Suture Sleeve
• 4 cm Suture Sleeve
Note: All contents of the inner package (or tray) are sterile and non-pyrogenic.
Contents of the Extension Kit
(55 cm)
• DBS Extension
• Torque Wrench
• Tunneling Tool Shaft (with Pre-Loaded Straw)
• Tunneling Tool Handle
Note: All contents of the inner package (or tray) are sterile.
Contents of the Tunneling Tool Kit
(28 cm, Straw and 35 cm, Long)
• Tunneling Tool Shaft (with Pre-Loaded Straw)
• Tunneling Tool Handle
Note: All contents of the inner package (or tray) are sterile.

Physician Manual
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Contents of the Spares Kit
• Lead Boot
• Lead Stop – Screw and Ring
• Torque Wrench
• 1 cm Suture Sleeve
• 1 cm Split Suture Sleeve
• 2.3 cm Suture Sleeve
• 4 cm Suture Sleeve
Note: All contents of the inner package (or tray) are sterile.
Other Components
• Remote Control with Batteries
• Remote Control Case
• Charger
• Base Station
• Power Supply
• Charging Collar (Small and Medium)
• Adhesive Patches
• Charging Spacer and Counterweight
• Clinician Programmer
• External Trial Stimulator
• External Trial Stimulator Battery
• OR Cable and Extension
• IR Interface
• IR Interface Holder
• USB to Serial Cable
• Patient Travel Case
• International Power Converter
• Remote Control Kit (Remote Control, Batteries, Case)
• Charging Kit (Charger, Base Station, Power Supply, Charging Collar)

DBS Lead Implantation
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DBS Lead Implantation
This section describes the recommended procedures for implanting the Vercise™
DBS System. Procedures for DBS Lead insertion and intra-operative testing are
outlined, followed by DBS Extension tunneling and Stimulator placement.
Note: Utilize meticulous care during implantation of the Vercise DBS System to
prevent infection.*
*Note: For additional information regarding recommended practices for the DBS procedure, please
see the following references -
Seijo F, Alvarez-Vega M, Lozano B, et al. (2009). “Common Questions and Answers to Deep
Brain Stimulation Surgery” In Rogers & Anderson (eds.), Deep Brain Stimulation. (pp. 1-29).
New York, NY: Nova Science Publishers, Inc.
Starr PA & Sillay K (2008). “Complication Avoidance and Management in Deep Brain
Stimulation Surgery” In Tarsy, Vitek, Starr & Okun (eds.), Deep Brain Stimulation in
Neurological and Psychiatric Disorders. (pp. 135-150). Totowa, NJ: Humana Press.
Umemura A (2007). “Complications and Avoidance” In Baltuch & Stern (eds.), Deep Brain
Stimulation for Parkinson’s Disease. (pp. 103-112). New York, NY: Informa Healthcare

Physician Manual
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Pre-Conditions
The described implant procedures start with implanting the DBS Lead. It is assumed
that the following procedures have been completed:
• The stereotactic frame and/or ducials of a frameless system are attached to
the patient.
• The desired trajectory of the DBS Lead insertion path has been determined.
• The incision in the scalp has been made and the burr hole drilled.
• If using the SureTek™ Burr Hole Cover, the Base of the Burr Hole Cover has
been afxed over the burr hole. (See the manual provided with the Burr Hole
Cover Kit for instructions for use.)
• The desired trajectory and DBS Lead depth may have been veried by
microelectrode recording or an appropriate means.
Implanting the DBS Lead
The DBS Leads will be implanted and therapeutic benet veried.
1. Prepare DBS Lead for implant. Visually inspect the DBS Lead and determine it
to be acceptable for implantation.
2. Pass the DBS Lead through the cannula to ensure proper t.
3. Insert the cannula (with stylet) into the brain to the desired depth.
Note: Cannula depth depends on physician’s preference.
4. Assemble the Lead Stop by partially screwing the
threaded portion of the Screw into the threaded hole
in the Ring.
5. Measure the desired depth of DBS Lead with a gauge
or ruler and apply the DBS Lead Stop at that length.