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Safety Information
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. 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. Depression, suicidal ideation, and suicide are known risks of DBS.
Consider adjustment of stimulation, discontinuing stimulation, adjusting medication,
and/or psychiatric referral.
Unauthorized Modification. Unauthorized modification to the medical devices is
prohibited. System integrity could be compromised and harm or injury to the patient
could occur if the medical devices are subjected to unauthorized modification.
Vercise™ DBS Physician Manual
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