Boston Scientific Vercise Mode D'emploi page 10

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Pregnancy: It is unknown whether this device may cause complications with pregnancy and/or
hurt an unborn baby.
Status Dystonicus (Dystonia Indication): Patients with dystonia require careful
monitoring for increase in symptom severity. Life‑threatening status dystonicus (also called dystonic
storm or dystonic crisis) can rarely occur. Status dystonicus may be triggered by the loss of DBS
therapy as well as by other factors and may lead to respiratory distress or failure, rhabdomyolysis,
multi‑organ failure, and death. Ensure that patients and caregivers understand the importance of
maintaining DBS therapy and that its loss for any reason (accidental turn‑off, battery depletion,
system failure) could cause symptom return and possible rebound, including status dystonicus.
Patients and caregivers should know how to use the Remote Control to ensure the system
is on and providing stimulation. Patients and caregivers also need to understand the correct
method for recharging the Stimulator (rechargeable Stimulator only). Healthcare providers and
patients/caregivers need to discuss the predicted time of battery replacement and plan ahead
for end of battery life procedures (non‑rechargeable Stimulator only). If symptoms return, the
patient/caregiver should contact the healthcare provider immediately.
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: New onset or worsening depression which may be temporary or permanent is a risk
that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are
events that have also been reported. Therefore, physicians should consider the following:
• Preoperatively, assess patients for the risks of depression and suicide. This assessment
should consider both the risk of depression and suicide as well as the potential clinical
benefits of DBS therapy for the condition being treated. Educate patients and caregivers
accordingly.
• Postoperatively, actively monitor patients for new or worsening symptoms of depression,
suicidal thoughts or behaviors, or changes in mood or impulse control.
• Consider adjustment of stimulation, discontinuing stimulation, or adjusting stimulation
and/or psychiatric referral.
Therapeutic Ultrasound: Implanted components of the Boston Scientific DBS System
should not be exposed to therapeutic levels of ultrasound energy. The implanted device may
concentrate the ultrasound field and may cause patient harm.
Unauthorized Modification: Unauthorized modification to the medical devices is prohibited.
The integrity of the DBS System could be compromised and harm or injury to the patient could
occur.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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