Precautions - Boston Scientific Vercise PC Instrucciones De Uso

Vercise™ PC Information for Prescribers
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.
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 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 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 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 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 Scientific 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.
Vercise™ PC Information for Prescribers
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