BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043422 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33223
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 80 YR Required Intervention THE DEVICE 4548/157726 WAS IMPLANTED 16-JAN-2008| THE DEVICE H217/714602 WAS IMPLANTED 16-JAN-2008| THE DEVICE 4136/282543 WAS IMPLANTED 16-JAN-2008| THE DEVICE 0185/186566 WAS IMPLANTED 05-FEB-2008