BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM VR

    MDR report key: 1072432 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00308
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 3, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R 6963 IMPLANTABLE PACING LEAD