BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1043013 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33626
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 86 YR Required Intervention THE DEVICE T165/138362 WAS IMPLANTED 30-JAN-2008| THE DEVICE 0185/186911 WAS IMPLANTED 13-FEB-2008| THE DEVICE 4136/245060 WAS IMPLANTED 30-JAN-2008| THE DEVICE 4136/245051 WAS IMPLANTED 13-FEB-2008