BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN IS-1/DF-1 - DR

    MDR report key: 1253605 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40350
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IS-1/DF-1 - DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC E110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other THE DEVICE 0185/210821 WAS IMPLANTED 02-SEP-2008| THE DEVICE 4136/283646 WAS IMPLANTED 02-SEP-2008