Precautions - Boston Scientific Vercise Gevia Instrucciones De Uso

Vercise Gevia™ Information for Prescribers
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
Gevia Stimulator and other active implantable devices such as pacemakers or cardioverter
defibrillators 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
Gevia 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 Gevia 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 difficult 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 Scientific and
intended for use with the Vercise Gevia 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, Charging System and
Clinician Programmer (CP) that were provided with the Boston Scientific Vercise Gevia DBS
System should be used with the Vercise Gevia DBS System. Other models of these devices will not
function with the Vercise Gevia 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 may require a revision surgery.
Vercise Gevia™ Information for Prescribers
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