BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE RX

    MDR report key: 1041635 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31913
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    October 7, 2005
    Report Date
    February 13, 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 ENDURANCE RX IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0144 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention THE DEVICE 4137/244711 WAS IMPLANTED 13-FEB-2008| THE DEVICE 1860/135629 WAS IMPLANTED 24-DEC-2003| THE DEVICE 0185/186225 WAS IMPLANTED 29-NOV-2007| THE DEVICE T175/128874 WAS IMPLANTED 13-FEB-2008