Multiple short circuits were noted along the electrode array and an x-ray revealed the electrode was kinked. Analysis of the device revealed electrode failure. Explantation/reimlantation surgery was performed.

Intermittent open and short circuis were detected on multiple electrodes. It cannot be ruled out that electrode damage occurred during explantation. The device passed all tests conducted to verify the proper operation of the stimulator. Bends, kinks, tears and exposed wires consistent with explantation were observed along the electrode lead and array. Approximately half way along the electrode lead, there was a tear observed with broken electrode wires visible within the tear. Kinks, cuts and exposed wires consistent with explantation were observed along the ball electrode lead, with the lead severed at approximately its midspan and not returned. There were tears observed in the silicone carrier of the device. No signs of body fluid were visible within the tears. X-rays of the device showed no anomalies aside from those described above. During testing, intermittent short circuits were detected on electrodes e1, e3, e15 and e20, intermittent open circuits were detected along electrodes e2, e6, and e22, and permanent open circuits were detected on electrodes e11, e12 and e17. At the location of the tear/broken electrode wires, open circuits were detected on electrodes e2, e6, e11, e12, e17 and e22. An open circuit was detected on e15 along the electrode array. The device passed all electrical testing conducted to confirm operation of the stimulator.