BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041583 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31944
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    December 19, 2006
    Report Date
    February 22, 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 IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention THE DEVICE T135/945336 WAS IMPLANTED 28-APR-2006| THE DEVICE 0185/187210 WAS IMPLANTED 20-FEB-2008