Boston Scientific Vercise Owner's manual

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Content: MP92366226-02 REV A
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.
Contacting Boston Scientic
To contact Boston Scientic, see the “Technical Support” section of this manual.
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 provided by your local sales representative after patient registration.

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Table of Contents
Device Description .......................................................................................... 1
Intended Use / Indications for Use.......................................................................... 2
Safety Information........................................................................................... 3
Contraindications..................................................................................................... 3
Warnings ................................................................................................................. 4
Precautions ............................................................................................................. 7
Adverse Events....................................................................................................... 13
Service and Maintenance................................................................................ 15
External Trial Stimulator (ETS) Maintenance .......................................................... 15
Cleaning the Charging System................................................................................ 16
Cleaning the Remote Control.................................................................................. 16
Cleaning the Programming Wand ........................................................................... 16
Electromagnetic Compatibility....................................................................... 17
EN 60601‑1‑2 Classication Information................................................................. 17
Notice to the User Per Industry Canada Radio Standards Specications............... 23
Essential Performance............................................................................................ 24
Telemetry Information.............................................................................................. 24
Quality of Wireless Service ..................................................................................... 25
Troubleshooting Wireless Coexistence Issues........................................................ 26
Wireless Security..................................................................................................... 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
Limited Warranty ‑ IPGs.................................................................................. 30
Rechargeable Implantable Pulse Generator (IPG).................................................. 30
Non‑Rechargeable Implantable Pulse Generator (IPG).......................................... 31
Limited Warranty ‑ Leads................................................................................ 32
Limited Warranty ‑ Externals.......................................................................... 33
Technical Support ........................................................................................... 34

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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.

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Intended Use / Indications for Use
The Boston Scientic DBS System is indicated for use in the following:
• Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus
pallidus (GPi) for levodopa‑responsive Parkinson’s disease that 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 that is not adequately controlled by
medications in patients diagnosed with Essential Tremor or Parkinson’s disease.
Additional Intended Use / Indication for Use for Vercise PC Only:
• 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.

Safety Information
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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.
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.

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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.
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 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 Boston Scientic DBS System,
causing tissue damage at the contact site resulting in severe injury or death.
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.

Safety Information
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• 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.
• 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.

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Pregnancy: It is unknown whether this device may cause complications with pregnancy and/or
hurt an unborn baby.
Status Dystonicus (Dystonia Indication): Patients with dystonia require careful
monitoring for increase in symptom severity. Life‑threatening status dystonicus (also called dystonic
storm or dystonic crisis) can rarely occur. Status dystonicus may be triggered by the loss of DBS
therapy as well as by other factors and may lead to respiratory distress or failure, rhabdomyolysis,
multi‑organ failure, and death. Ensure that patients and caregivers understand the importance of
maintaining DBS therapy and that its loss for any reason (accidental turn‑off, battery depletion,
system failure) could cause symptom return and possible rebound, including status dystonicus.
Patients and caregivers should know how to use the Remote Control to ensure the system
is on and providing stimulation. Patients and caregivers also need to understand the correct
method for recharging the Stimulator (rechargeable Stimulator only). Healthcare providers and
patients/caregivers need to discuss the predicted time of battery replacement and plan ahead
for end of battery life procedures (non‑rechargeable Stimulator only). If symptoms return, the
patient/caregiver should contact the healthcare provider immediately.
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: 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. Educate patients and caregivers
accordingly.
• Postoperatively, actively monitor patients for new or worsening symptoms of depression,
suicidal thoughts or behaviors, or changes in mood or impulse control.
• Consider adjustment of stimulation, discontinuing stimulation, or adjusting stimulation
and/or psychiatric referral.
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.