MEDTRONIC DUAL CHAMBER PACEMAKER

Description of Event or Problem

PATIENT SUFFERED EPISODE OF SYNCOPE WITH PERIOD OF ASYSTOLESHOCKED; STABLEIZED; ADMITTED; PACEMAKER LEAD WIRE, BATTERY REPLACEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER, BATTERY/PACK. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.