BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1002420 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31883
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    December 21, 2006
    Report Date
    December 21, 2006
    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 77 YR Required Intervention THE DEVICE 4470/463230 WAS IMPLANTED 11-MAR-2005| THE DEVICE H170/506480 WAS IMPLANTED 11-MAR-2005| THE DEVICE 4542/104281 WAS IMPLANTED 11-MAR-2005| THE DEVICE H177/285813 WAS IMPLANTED 22-DEC-2006