BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1946124 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20154
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    September 16, 2010
    Report Date
    October 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) JUST AFTER WOUND CLOSURE NOISE WAS NOTED ON THE VENTRICULAR CHANNEL AND THE PATIENT RECEIVED INAPPROPRIATE ANTI TACHYCARDIA PACING (ATP) THERAPY WHILE A SHOCK WAS DIVERTED AFTER REDETECTION. THE PATIENT WAS RE-OPENED AND MEASUREMENTS WERE ALL NORMAL WHEN TESTED BY THE PACING SYSTEM ANALYZER (PSA). FINALLY, THE PHYSICIAN DISCOVERED THAT THE IS-1 CONNECTION WAS LOST AND UPON RECONNECTING THE LEAD INTO THE DEVICE NOISE WAS NO LONGER SEEN ON THE VENTRICULAR CHANNEL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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