BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1002411 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31894
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    September 5, 2007
    Report Date
    September 5, 2007
    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 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention THE DEVICE 6481 021641 WAS USED DURING THE EVENT.| THE DEVICE 4269/249128 WAS IMPLANTED 10-MAY-1996| THE DEVICE H177/281683 WAS IMPLANTED 24-AUG-2005