BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042675 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33958
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 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 G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention THE DEVICE 4513/404188 WAS IMPLANTED 26-NOV-2004| THE DEVICE H179/501319 WAS IMPLANTED 24-NOV-2004| THE DEVICE H175/100596 WAS IMPLANTED 07-MAY-2004| THE DEVICE 4518/305856 WAS IMPLANTED 24-NOV-2004| THE DEVICE 4512/401472 WAS IMPLANTED 07-MAY-2004| THE DEVICE 4524/150104 WAS IMPLANTED 26-NOV-2004