Boston Scientific Vercise Gevia Instrucciones De Uso página 9

Safety Information
Patients should be instructed not to change the orientation of or turn over the Stimulator. If the
Stimulator flips over in the body, then it cannot be charged. If stimulation cannot be turned on after
charging, the Stimulator may have changed orientation or rotated; patients should contact their
physician to arrange an evaluation of the system.
Patients should avoid touching the Stimulator site or incisions. If a patient notices a change in
appearance of the skin at the Stimulator location, such as the skin becoming thin over time, they
should contact their physician.
Setscrews. Before tightening Setscrews, always test impedance to confirm electrical
connectivity. Tightening a Setscrew onto a contact may damage the contact and may result in the
need to replace the DBS Lead or DBS Extension.
Sutures. Do not apply sutures tightly around the DBS Leads, as this may damage the insulation
of the DBS Lead and may result in DBS Lead failure.
Surgical Tape. If tape is used to temporarily secure the DBS Lead during surgery, caution
should be used to ensure the Lead is not cut or damaged when removing the tape.
Device Failure. Implants can fail at any time due to random component failure, loss of battery
functionality, or DBS Lead breakage. Suddenly stopping brain stimulation can cause serious
reactions to develop. If the Stimulator stops working even after complete charging (up to four hours
when properly aligned), patients should be instructed to turn off the Stimulator and contact their
physician immediately so that the system can be evaluated and appropriate medical care given to
manage the return of symptoms.
Tissue Reaction. Temporarily, there may be some pain in the area of the Stimulator as the
incisions heal. If there is excessive redness around the wound area, it should be checked for
infection. In rare cases, adverse tissue reaction to implanted materials can occur.
Cell Phones. While interference caused by cell phones is not anticipated, the full effects of
interaction with cell phones are unknown at this time. Patients should be instructed to avoid placing
the cell phone directly over the Implanted Stimulator. If interference does occur, move the cell
phone away from the Implanted Stimulator or turn off the phone.
Patient Activities. During the two weeks following surgery, it is important for the patient to
exercise extreme care so that appropriate healing will secure the implanted components. During
this period, the patient should not attempt to move heavy objects. Instruct the patient to restrict
head movements, including extension or flexion of the neck and rotation of the head, until healing
is complete.
Massage Therapy. Patients should avoid receiving massage therapy near the implanted
system components. If a patient does receive massage therapy, the patient should inform the
masseuse that they have an implanted device and show him/her where the Stimulator, DBS
Extension, and DBS Leads are located. The patient should have the masseuse avoid these areas
and proceed with caution.
Environmental Precautions. Patients should avoid activities that could potentially involve
large amounts of electromagnetic interference. Devices that contain permanent magnets, such as
speakers, should not be placed near the Stimulator because they may cause the system to turn on
or off.
Vercise Gevia™ Information for Prescribers
91168753-02 Rev A 5 of 505