Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Reason: Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

Code information: UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A

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