Description of Event or Problem · 1
PATIENT HAD A MEDTRONIC PACEMAKER GENERATOR AND LEAD INSERTED ON 10/2/92. WITHIN A FEW DAYS IT BECAME EVIDENT THAT SOME COMPONENTS OF THE FIRING WERE NOT WORKING. THE PATIENT THEREFORE RETURNED TOTHE OR AND HAD NEW GENERATOR ATTACHED TO THE EXISTING LEAD. FOLLOWING THAT THE DEVICE FUNCTIONED PROPERLY. MEDICAL PEER REVIEW WAS DONE ON 11/2/92 AND ATTRIBUTED THE EVENT SOLELY TO GENERATOR FAILURE. THE GENERATOR WAS RETURNED TO THE MANUFACTURER ON 10/6/92 (GIVEN TO SALESMAN)DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.