BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELIGEN

    MDR report key: 1705168 · Received June 1, 2010

    Report

    Report Number
    2124215-2010-11848
    Event Type
    Death
    Date Received
    June 1, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. AFTER A REVIEW OF THE STORED EPISODES THE DATE OF DEATH WAS CONFIRMED. ALL EPISODES PRIOR TO THE PATIENT'S DEATH WERE APPROPRIATELY DETECTED AND TREATED. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DIED IN A CAR ACCIDENT. IT WAS REPORTED THAT THE PATIENT HAD A VENTRICULAR FIBRILLATION (VF) EPISODE NEAR THE TIME OF THE CAR ACCIDENT. THE ICD DELIVERED EIGHT FORTY-ONE JOULE SHOCKS IN THE VF ZONE AND THE EPISODE LASTED TWENTY MINUTES. THE EPISODE WAS FLUCTUATING BETWEEN THE VENTRICULAR TACHYCARDIA (VT) ZONE AND THE VF ZONE. ALL THERAPY WAS EXHAUSTED, AS EIGHT SHOCKS IS THE MAXIMUM NUMBER OF SHOCKS PER EPISODE. SUBSEQUENTLY, THERE WERE THREE ADDITIONAL EPISODES DECLARED WHERE SHOCKS WERE DELIVERED. THERE WERE NO DEVICE ALLEGATIONS. THE CAUSE OF DEATH WAS DETERMINED TO BE CARDIAC ARREST. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death A155| 0185| 4469| E110