Description of Event or Problem · 1
74 YEAR OLD MALE, IN OR FOR BURR HOLES TO EVACUATE SUB-DURAL HEMATOMA. PACEMAKER SINCE 1987, HAD GENERATOR AND LEAD CHANGED IN NOVEMBER, 1991. PACEMAKER FUNCTIONING WELL PRIOR TO EVENT. ELECTROSURGICAL UNIT, UNIPOLAR, WITH COAG SET AT 35, CUT 35 PRESENT AND IN USE. GROUND ON LEFT THIGH. CARDIAC ARRESTED 12 MINUTES INTO PROCEDURE. CPR C RYTHM ESTABLISHED THREE MINUTES. NO PACEMAKER FUNCTION OR RESPONSE TO MAGNET OR REPROGRAMMING. GENERATOR CHANGED 1/21/93 WITH GOOD FUNCTION. PATIENT SURVIVEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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. RESULTS OF EVALUATION: MAGNET RESPONSE FAILURE, PROGRAMMING FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.