Vercise Genus
Deep Brain Stimulation System
TM
Device‑Related Risks
•
Allergic or immune system response to implanted materials
•
Failure or malfunction of any part of the device. This may or may not require device removal and/or replacement. This
includes, but is not limited to:
- Battery leakage
- Battery failure
- Lead or Lead Extension breakage
- Hardware malfunctions
- Loose connections
- Electrical shorts or open circuits
- Lead insulation breaches
•
Implant site complications, such as:
- Pain
- Poor healing
- Redness
- Warmth
- Swelling
- Wound reopening
•
Implanted device components (IPG, Lead, or Lead Extension) may move from the original implanted location or wear
through the skin, which may require additional surgery
Information for Patients
92694767-14
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