BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1041448 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32088
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 2, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention THE DEVICE H175/315552 WAS IMPLANTED 12-JUL-2006| THE DEVICE 4087/254626 WAS IMPLANTED 12-JUL-2006| THE DEVICE 6481 030691 WAS USED DURING THE EVENT.| THE DEVICE 4518/321723 WAS IMPLANTED 12-JUL-2006