Boston Scientific Vercise PC Instrucciones De Uso página 9

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, 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. 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.
Medical Devices/Therapies. The following medical therapies or procedures may turn
stimulation off, cause permanent damage to the Stimulator, or may cause injury to the patient:
• Electrocautery – Electrocautery can transfer destructive current into the DBS Leads and/
or Stimulator.
• External Defibrillation – Safe usage of external defibrillation has not been established
and damage should be ascertained following defibrillation.
• Lithotripsy – High frequency signals directed near the Stimulator may damage circuitry.
Safety Information
Vercise™ PC Information for Prescribers
92190993-02 5 of 459