BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM

    MDR report key: 1082829 · Received July 17, 2008

    Report

    Report Number
    1082829
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT CALLED CLINIC STATED THAT DEVICE WAS BEEPING, AND WAS BROUGHT INTO THE CLINIC THE SAME DAY. WHEN DEVICE INTERROGATED, OBSERVATION WINDOW SHOWED "THE CHARGE CIRCUIT IS INACTIVE, THERAPIES WILL NOT BE DELIVERED." CONTACTED MEDTRONIC AND THEY STATED THAT THE DEVICE COULD NOT BE REPROGRAMMED AND NEEDED TO BE CHANGED OUT. PT TRANSFERRED TO ANOTHER FACILITY ON CARDIAC MONITOR FOR DEVICE CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM AICD LWS MEDTRONIC, INC. CARDIAC RHYTHM DISEASE MANAGEMENT GEM 7227 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR