Boston Scientific Neuromodulation Corporation device recall (Cls II)

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. — Status: Ongoing