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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
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.
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/cm
software will display a warning when the level of stimulation exceeds 30 µC/cm
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.
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 Scientific recommends placing the DBS Extension connector behind
the ear such that glasses or headgear do not interfere with the system. Boston Scientific
recommends that the Stimulator be placed subclavicularly.
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.
Electromagnetic Interference. Strong electromagnetic fields 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, tag deactivators and RFID devices, such as those used at
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.
per stimulation phase. To maintain safety limits, the
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Safety Information
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Vercise™ DBS Physician Manual
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