Boston Scientific Vercise DBS Mode D'emploi page 11

Safety Information
Sutures. Do not apply sutures tightly around the DBS Leads, as this may damage
the DBS Leads' insulation 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 with cell phones is not anticipated, the full effects
of interaction with cell phones are unknown at this time.
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.
Physician Manual
91098825-07 Rev A 7 of 333