BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041397 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32149
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    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 DTB CARDIAC PACEMAKERS, INC 0148 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention THE DEVICE 0148/ WAS IMPLANTED| THE DEVICE 1861/236609 WAS IMPLANTED 30-OCT-2002| THE DEVICE 4087/152114 WAS IMPLANTED 30-OCT-2002