BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210899 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07565
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ATRIAL FLUTTER ABLATION THERE WAS OCCASIONAL LOSS OF CAPTURE WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DESPITE ELECTROCAUTERY MODE BEING ON. NO ASYSTOLE GREATER THAN TWO SECONDS WAS OBSERVED. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND POTENTIAL REASONS FOR THE OBSERVATION WERE DISCUSSED ALONG WITH OPTIONS TO MINIMIZE REOCCURRENCE. DUE TO WORSENING HEART FAILURE THE PATIENT UNDERWENT AN UPGRADE PROCEDURE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS DEVICE WAS EXPLANTED, THERE WERE NO PERFORMANCE ISSUE THAT CONTRIBUTED TO THE EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311780 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR E110| 4470| 0185