BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1873933 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18006
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING DEFIBRILLATION THRESHOLD TESTING (DFT) WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THIS PATIENT EXPERIENCED NON-CONVERSION WITH A 25 AND 41 JOULE SHOCK. SUBSEQUENTLY, THE PATIENT REQUIRED EXTERNAL CONVERSION DUE TO PULSELESS ELECTRICAL ACTIVITY (PEA). THE PATIENT HAD AN EJECTION FRACTURE OF 10% AND WAS ON MULTIPLE HEART FAILURE MEDICATIONS. A SUB Q ARRAY WAS IMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE. ADDITIONAL DFT TESTING WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening| R MISMATCH| 0181| E102