BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1952196 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23444
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS IMPLANTED IN (B)(6) 2010. THE ASSOCIATED COMPETITOR RIGHT VENTRICULAR LEAD DISLODGED LEADING TO MULTIPLE INAPPROPRIATE SHOCKS AND SYNCOPE. THE DISLODGEMENT POSITIONED THE LEAD AT THE VALVE, IRRITATING THE HEART AND DOUBLE COUNTING T AND R WAVES. THIS PATIENT IS PACEMAKER DEPENDENT AND PACING INHIBITION WAS OBSERVED DUE TO TORSADES DE POINTES. THE COMPETITOR LEAD WAS REPOSITIONED. UPON REPOSITIONING AND REPROGRAMMING THE DEVICE LONGEVITY IMPROVED SUBSTANTIALLY. CURRENTLY, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL PATIENT EFFECTS REPORTED.

    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 62 YR Life Threatening| R 6937| T125| 6943| 1821| E110| 4269| 1861| 5076| 7120