SAFETY INFORMATION AND RISKS
Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through your skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may cause new or worsening neurological symptoms, including motor and speech, and psychiatric disorders.
In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.
For complete safety information about Medtronic DBS Therapy, please consult your doctor, call Medtronic at 800-328-0810, or go to Important Safety Information.