BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1042069 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34584
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 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 EZ IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0154 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention THE DEVICE H210/209849 WAS IMPLANTED 04-DEC-2007| THE DEVICE 4470/301110 WAS IMPLANTED 01-AUG-2001| THE DEVICE 4193/ WAS IMPLANTED 04-APR-2004