Description of Event or Problem · 1
AFTER REMOVAL OF ACID PATCHES, LEADS, AND REPAIR OF LEFT VENTRICAL ON 1.19.93 PATIENT WAS TRANSFERRED TO THE CCU WHERE HE EXPIRED. AFTER THE SURGEON REVIEWED THE AUTOPSY REPORTS HE STATED THAT A SIGNIFICANT COMPLICATION OF HIS AICD IMPLANT WAS THE CAUSE OF HIS DEATH. THE PATIENT HAD A CHRONIC PROBLEM WITH THE UNIT ERODING THROUGH HIS RECTUS MUSCLE SEVERAL TIMES SINCE IT WAS IMPLANTED ORIGINALLY. THE EROSION OF THE PATCH THROUGH THE LEFT VENTRICULAR WAS SOMEWHAT OF A SURPRISE. OTHER DEVICES USED INCLUDED: CPI LARGE PATCH LEAD;CPI MYCARDIAL LEAD SUTURELESS. A SEPERATE REPORT INCLUDING COPY OF DISCHARGE SUMMARY AND THE PRELIMINARY AUTOPSY REPORT HAD BEEN FORWARDED TO CPI AND THE FDA WITH A COVER LETTER FROM THE SURGEONDEVICE 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, UNANTICIPATED ADVERSE REACTION - LONG TERM. CONCLUSION: SOFTWARE/FIRMWARE CAUSED EVENT, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.