MEDTRONIC-HALL

Description of Event or Problem

PATIENT ARRIVED IN OPERATION ROOM AS EMERGENCY ON JANUARY 31, 1993 FOR REDO MITRAL VALVE (IMPLANTED 1/6/93) REPLACEMENT USING A #31 PROSTHESIS. PATIENT WAS IN CRITICAL CONDITION IN ICU UNTIL 2/2/93 PATIENT WAS PRONOUNCED DEAD AT 9:35 ON THE MORNINGDEVICE 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. 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, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER, INHERENT RISK OF PROCEDURE, LEAFLET. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.