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Patient 1
THE PATIENT HAS A HISTORY OF ATRIOVENTRICULAR BLOCK/SINUS ARREST WITH SYNCOPE. A PACEMAKER WAS INITIALLY IMPLANTED DURING 1970 AND WAS REPLACED ON SEVERAL OCCASIONS, THE MOST RECENT BEING 7/20/89. THE PATIENT PRESENTED TO THE HOSPITAL ON 1/23/92 FOR PACEMAKER CHECK AND THE UNIT WAS NOTED TO BE NOT SENSING. THE LEAD POSITION WAS SATISFACTORY AND A "BENCH TEST DONE BY INTERMEDICS PACING SYSTEMS ANALYZER REVEALED THAT NO SENSING PARAMETERS COULD BE TELEMETERED. THUS, PULSE GENERATOR MALFUNCTION WAS SUSPECTED. ON 1/24/92, THE PULSE GENERATOR WAS REMOVED AND REPLACED UNDER LOCAL ANESTHESIA. THE PATIENT IS DOING WELL POST-OPERATIVELY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-91. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM, NONE OR UNKNOWN, NONE OR UNKNOWN, RATE-MODULATED PACING SENSING FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.