Boston Scientific Vercise PC Manual

Vercise™ PC
Information for
Prescribers
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Directions for Use
Instrucciones de uso
Mode d’emploi
Gebrauchsanweisung
Istruzioni per l’uso
Gebruiksaanwijzing
Bruksanvisning
Käyttöohje
Bruksanvisning
Brugsanvisning
Instruções de Utilização
Instruções de uso
Kullanım Talimatları
Указания по использованию
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Návod k použití
Návod na použitie
Instrukcja obsługi
Használati utasítások
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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.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their respective holders.
Additional Information
For other device-specic information not included in this manual, or labeling symbols, refer to the
appropriate DFU as listed on your DBS Reference Guide.
Registration Information
In accordance with international practice and regulatory legislation in some countries, a registration
form is packed with each Boston Scientic Stimulator, DBS Lead, and DBS Extension. The purpose
of this form 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.
Fill out the registration form included in the package contents. 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

Table of Contents
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Table of Contents
Vercise™ PC DBS System Description ...................................... 1
Intended Use / Indications for Use.............................................. 1
Safety Information........................................................................ 2
Contraindications .................................................................................2
Warnings ........................................................................................2
Precautions ...................................................................................4
Adverse Events ..............................................................................8
External Trial Stimulator 2 (ETS 2) Maintenance....................... 11
Vercise PC Stimulator Battery..................................................... 11
Elective Replacement ...........................................................................12
End of Service ......................................................................................12
Limited Warranty - Implantable Pulse Generator
(Stimulator) ................................................................................... 13
Non-Rechargeable Stimulator...............................................................13
Limited Warranty - Leads ............................................................ 14
Limited Warranty - Externals....................................................... 15
Technical Support ....................................................................... 17

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Vercise™ PC DBS System Description
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Vercise™ PC DBS System Description
The Vercise PC Deep Brain Stimulation (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
Vercise PC DBS System utilizes current steering across eight contacts per DBS Lead to provide
precise positioning of stimulation. The Stimulator is controlled by a hand-held Remote Control, and
can be interfaced with a Clinician’s Programmer.
The battery of the non-rechargeable stimulator will become depleted. The longevity of the
Stimulator battery depends on the following factors:
• Programmed parameters
• System impedance
• Hours per day of stimulation
• Changes to stimulation made by the patient
For additional information on estimating the longevity of the non-rechargeable battery, refer to the
appropriate programming manual as listed on your DBS Reference Guide.
Note: The Vercise PC System was not made with natural latex.
Intended Use / Indications for Use
The Vercise PC DBS 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.

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Safety Information
Contraindications
The Boston Scientic Vercise PC DBS System, or any of its components, is contraindicated for the
following:
Diathermy. Shortwave, microwave, and/or therapeutic ultrasound diathermy. The energy
generated by diathermy can be transferred to the Vercise PC DBS System, causing tissue damage
at the contact site resulting in severe patient injury or death.
Magnetic Resonance Imaging (MRI). Patients implanted with the Vercise PC
DBS System 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 even death
Patient Incapability. Patients who are unable to properly operate the Remote Control should
not be implanted with the Vercise PC DBS System.
Poor Surgical Risks. The Vercise PC DBS System is not recommended for patients who are
poor surgical risks.
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. To maintain safety
limits, the software will display a message when the stimulation level would exceed the limit, and
programming of these settings will be prevented.
Patients may be granted the ability to change stimulation amplitude with the Remote Control. The
software prevents patient controlled amplitude from violating the limit.

Safety Information
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Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used
on patients implanted with the Vercise PC 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 PC DBS System, causing tissue
damage at the contact site resulting in severe injury or death.
Magnetic Resonance Imaging. Patients implanted with the Vercise PC DBS System,
or any of its components, should not be subjected to Magnetic Resonance Imaging (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 components
causing unpredictable levels of stimulation
• Distortion of the diagnostic image
• Personal injury or even death
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 the
following:
• 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.

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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. Concurrent use of stimulators such as the Vercise PC
Stimulator and other active implantable devices such as pacemakers or cardioverter debrillators
may result in interference with the operations of the devices. If the patient requires concomitant
implantable active devices, careful programming of each system is necessary.
Automobiles and Equipment. Patients should operate automobiles, other motorized
vehicles, or potentially dangerous machinery/equipment with caution after receiving the Vercise PC
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.
Precautions
Physician training is required for usage of the Vercise PC 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 sterile, 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 PC 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.
Other Models of External Devices. Only the Remote Control and Clinician Programmer
that were provided with the Boston Scientic Vercise PC DBS System should be used with the
Vercise PC DBS System. Other models of these devices will not function with the Vercise PC DBS
System.
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 appearance of the skin at the Stimulator
location, such as the skin becoming thin over time, they should contact their physician.

Safety Information
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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.
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.
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, 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.
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.

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• 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 Vercise PC DBS System should not be subjected to
MRI to avoid damage to the device and patient harm.
• Diathermy – The energy generated by diathermy can be transferred to the Vercise PC
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.
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 External Trial Stimulator, Remote
Control, and Programing Wand is 5–40 °C (41–104 °F).