BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2040887 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00952
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS DEVICE REMAINS IMPLANTED NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT OF RANGE PACING IMPEDANCES AT A FOLLOW UP. THE IMPEDANCE HAD RISEN SINCE THE IMPLANT PROCEDURE AND REMAINED OUT OF RANGE. AT THIS TIME NO FURTHER ACTION HAS BEEN TAKEN AND THE DEVICE AND COMPETITOR RIGHT VENTRICULAR LEAD REMAIN IMPLANTED.

    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 57 YR MISMATCH| 1872| (B)(4)| 0138