BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1042216 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34423
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 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 IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THE DEVICE 4518/319343 WAS IMPLANTED 08-FEB-2006| THE DEVICE H175/314762 WAS IMPLANTED 08-FEB-2006| THE DEVICE 4285/310071 WAS IMPLANTED 04-FEB-2003