BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1041913 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34736
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 70 YR Required Intervention THE DEVICE 4087/235766 WAS IMPLANTED 05-APR-2005| THE DEVICE T125/112867 WAS IMPLANTED 05-APR-2005| THE DEVICE 0062/002855 WAS IMPLANTED 15-NOV-1993