BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN IS-1/DF-1 - VR

    MDR report key: 1253556 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40045
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IS-1/DF-1 - VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC F102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE 6628 WAS USED DURING THE EVENT.| THE DEVICE 0128/105654 WAS IMPLANTED| THE DEVICE F102/ WAS IMPLANTED