BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041582 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31943
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    December 7, 2006
    Report Date
    February 8, 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 0137 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THE DEVICE A135/105362 WAS IMPLANTED 16-APR-2004| THE DEVICE 0184/139780 WAS IMPLANTED 08-FEB-2008| THE DEVICE T180/214729 WAS IMPLANTED 08-FEB-2008