Description of Event or Problem · 1
ON DECEMBER 18, 1991, AT 3:00 P.M., IN THE OPERATING ROOM, A FOURTY-FIVE YEAR OLD FEMALE WAS UNDERGOING A MITRAL VALVE REPLACEMENT WIRE. ADDITIONALLY, A DIME SIZED LESION AT THE SITE OF THE GROUNDING WIRE WAS NOTED. THE PATIENT'S VITAL SINGS WERE NOT AFFECTED.OUR PRELIMINARY INVESTIGATION REVEALS THAT THE MEDTRONIC A-V SEQUENTIAL DEMAND PULSE GENERATOR MALFUNCTIONED. THE EQUIPMENT WAS TAKEN OUT OF SURVICE AND SEQUESTERED. WE ARE ADVISING YOU OF THIS INFORMATION IN ACCORDANCE WITH THE SMDA OF 1990INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. INVALID DATA - WHETHER 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: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.