Description of Event or Problem · 1
IN 10/91, THIS 71-YEAR-OLD MALE PT WAS EVALUATED FOR CORONARY ARTERY DISEASE AND VENTRICULAR TACHYCARDIA. ON 10/17/91, THE PT UNDERWENT CORONARY ARTERY BYPASS GRAFT (3 VESSELS) AND PLACEMENT OF AICD PATCHES (LARGE LEAD (2) 0041-142167/0041-142169) (SMALL LEAD 0040-112004) (CONNECTOR 6836-001-490). ON 11/04/91, AN AICD WAS PLACED. IN ADDITION TO THE AICD, THE FOLLOWING WERE PLACED: LEAD CONNECTS, MODEL NO 6836, SERIAL NO 6836-000978; LEAD CONNECTOR, LOT NO 191056, 6836-000978; AND VENA CAVA LEAD, MODEL NO C10, SERIAL NO 0020-101272-640020. THE REPORTING INSTITUTION WAS NOTIFIED THAT THE PT HAD EXPIRED ON 5/11/93. DETAILS OF THE PT'S DEATH WERE NOT PROVIDED, BUT THE DEVICE WAS RETURNED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.