BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042882 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33772
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 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 0165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 0185/190003 WAS IMPLANTED| THE DEVICE T167/111821 WAS IMPLANTED| THE DEVICE 4480/493457 WAS IMPLANTED