BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2151676 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06038
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, AN X-RAY REVEALED ALL HEADER WIRES APPEARED NORMAL. THE SETSCREWS AND SEALPLUGS APPEARED NORMAL. THIS DEVICE WAS SUBJECTED TO SIMULATED HEART LOAD CONDITIONS AND THE PACING, SENSING, AND DEFIBRILLATION 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. ANALYSIS CONFIRMED THIS DEVICE MET SPECIFICATION AND COULD NOT DETERMINE A REASON FOR THE REPORTED CLINICAL ALLEGATIONS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND WAS NOT STIMULATING APPROPRIATELY. THIS DEVICE WAS IMPLANTED IN THE SUB-PECTORAL POSITION AND IS INCLUDED IN THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY INITIALLY COMMUNICATED ON (B)(6) 2009. A VISUAL INSPECTION REVEALED THE LEADS APPEARED APPROPRIATELY SEATED IN THE DEVICE HEADER AND WHEN TUGGED LIGHTLY, THE CONNECTION APPEARED TIGHT. WHEN THE DEVICE HEADER WAS MANIPULATED, NOISE WAS NOTED. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL LIMITS. A REPLACEMENT PROCEDURE WAS PERFORMED. IT WAS THOUGHT THE REPORTED ISSUE WAS DUE TO THE DEVICE. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. THE RIGHT VENTRICULAR LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE AND REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention