BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042017 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34616
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention THE DEVICE 4469/493535 WAS IMPLANTED 12-MAR-2008| THE DEVICE H215/710018 WAS IMPLANTED 12-MAR-2008| THE DEVICE 4518/330463 WAS IMPLANTED 12-MAR-2008