BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211179 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08678
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ALERT WAS TRIGGERED DUE TO OUT OF RANGE SHOCKING IMPEDANCES ON THIS DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A FOLLOW UP WAS SCHEDULED. AT THIS TIME A FOLLOW UP HAS BEEN PERFORMED AND THE SYSTEM REMAINS IMPLANTED WITH HIGH TREND IMPEDANCE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310452 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1