BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1043396 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33253
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 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 0155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention THE DEVICE T175/110837 WAS IMPLANTED 10-MAY-2006| THE DEVICE 4471/ WAS IMPLANTED