Product Info
Safety Information
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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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
Scientic 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‑dened 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 Scientic 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.