Boston Scientific Vercise Genus Bedienungsanleitung Seite 33

Adverse Events
Not all risks with the use of deep brain stimulation are known. The following is a list of known risks. If any of these events
occur, inform your healthcare provider as soon as possible. Report any serious incident that occurs in relation to this device to
Boston Scientific and to the relevant local regulatory authority for medical devices in your country. For customers in Australia,
report any serious incident that occurs in relation to this device to Boston Scientific and to the Therapeutic Goods Administration
(https://www.tga.gov.au).
Risks Associated with Surgical Procedure and Post‑Operative Period
• Blood clot forming, for example in the veins of the legs
• Blood clot or air in the blood stream, which can block blood flow to parts of the lungs or other tissue
• Cerebral spinal fluid (CSF) that normally surrounds the brain leaking outside the skull
• Confusion or problems with attention, thinking, or memory
• Death
• Infection
• Injury to areas next to the implant, such as blood vessels, nerves, the chest wall, and the brain
• Neurosurgery and anesthesia risks, including unsuccessful implant and pneumonia
• Pain, headache, or discomfort
• Seizures
• Status dystonicus
• Stroke, resulting in temporary or permanent problems, such as paralysis or difficulty speaking
• Swelling or bruising
Safety Information
Information for Patients
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