BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2053061 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03751
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCKING IMPEDANCES. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IMPLANTED. 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 F111

    Patients

    Seq Age Sex Outcome Treatment
    1