REPORTER INDICATED THAT THE VNS PATIENT UNDERWENT REIMPLANTATION OF THE VNS SYSTEM DUE TO HIGH LEAD IMPEDANCE. DURING THE INVESTIGATION OF THE HIGH IMPEDANCE, IT WAS CONFIRMED THAT THE NORMAL MODE AND SYSTEM DIAGNOSTICS RESULTS PRIOR TO THE REIMPLANT SURGERY, RESULTED IN LEAD IMPEDANCE HIGH INDICATING A POSSIBLE LEAD BREAK. REPORTED REVIEW OF THE X-RAYS BY THE SITE DID NOT SHOW ANY LEAD DISCONTINUITIES AND THE IMPLANTING PHYSICIAN REPORTED THAT HE DID NOT VISUALIZE ANY LEAD DISCONTINUITIES DURING THE REIMPLANT PROCEDURE. APPROXIMATELY 38CM OF THE LEAD ASSEMBLY WAS RETURNED FOR EVALUATION IN ONE PIECE WITH THE LEAD CONNECTORS. THE ELECTRODE PORTION OF THE LEAD WAS NOT RETURNED. THE PRODUCT ANALYSIS COMPLETED ON THE RETURNED PIECE DID NOT SHOW ANY LEAD DISCONTINUITIES.
N
Patient 1
THE ENTIRE LEAD ASSEMBLY WAS NOT RETURNED FOR PRODUCT ANALYSIS. THE PORTION TESTED DID NOT INDICATE DEVICE FAILURE, HOWEVER, CYBERONICS SUSPECTS THE MALFUNCTION OCCURRED IN THE PORTION OF THE LEAD NOT RETURNED. DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.