BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042112 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34543
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 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 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 011889 WAS USED DURING THE EVENT.| THE DEVICE 4469/480402 WAS IMPLANTED 17-SEP-2007| THE DEVICE T167/108073 WAS IMPLANTED 25-APR-2007