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Patient 1
DURING A GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION, THE PATIENT PRESENTED WITH HIGH IMPEDANCE ONCE THE NEW GENERATOR WAS CONNECTED TO THE LEAD (CAPTURED IN THIS MFR. REPORT). PRE-OP DIAGNOSTICS COULD NOT BE PERFORMED TO DETERMINE THE IMPEDANCE, SINCE THE PATIENT'S GENERATOR HAD REACHED END OF SERVICE. THE LEADS WERE ADJUSTED, THE SURGEON CHECKED FOR ANY VISUAL FRACTURES, TOOK STEPS TO RELIEVE BACK PRESSURE, MADE SURE THE NERVE WAS IRRIGATED AND MULTIPLE SYSTEM DIAGNOSTIC TESTS WERE PERFORMED BUT HIGH IMPEDANCE WAS STILL OBSERVED. GENERATOR DIAGNOSTICS WERE PERFORMED WITH A TEST RESISTOR AND THE IMPEDANCE WAS NORMAL, SO A GENERATOR ISSUE WAS RULED OUT. THE SURGEON THEN REPLACED THE LEAD AND CHECKED FOR CORRECT PLACEMENT ON THE NERVE AND HIGH IMPEDANCE WAS STILL OBSERVED, THIS IS CAPTURED IN MFR. REPORT #1644487-2020-00141. THE LEAD WAS THEN REPLACED AGAIN AND HIGH IMPEDANCE WAS STILL OBSERVED AND THE PATIENT WAS CLOSED, THIS IS CAPTURED IN MFR. REPORT #1644487-2020-00140. A REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THE LEAD PASSED QUALITY CONTROL INSPECTION PRIOR TO DISTRIBUTION FOR THE LEAD THAT WAS OPENED BUT NOT USED. THE SURGEON THEN MENTIONED THAT SHE IS UNSURE OF THE CAUSE OF THE HIGH IMPEDANCE, BUT A FAIRLY THICK LAYER OF FIBROUS TISSUE WAS OBSERVED ON THE PATIENT'S NERVE. THE EXPLANTED GENERATOR AND LEAD HAS BEEN RECEIVED BY PA, BUT PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. NO FURTHER SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.