BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY EZ PATIENT PROGRAMMER

    MDR report key: 1032174 · Received April 21, 2008

    Report

    Report Number
    6000031-2008-02112
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 22, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELL ON A WET FLOOR AT THE GROCERY STORE. AT THE TIME OF THE FALL, THE DEVICE WAS TURNED OFF. THE PT TURNED ON THE DEVICE IN ORDER TO GET UP FROM THE FALL AND WAS UNABLE TO DECREASE THE STIMULATION ONCE IT WAS TURNED ON DUE TO THE PROGRAMMER BECOMING WET FROM THE FALL. THE PT WAS ADMITTED TO THE HOSP AS THE PT WAS UNABLE TO TURN DOWN THE STIMULATION THAT HAD BECOME TOO HIGH AND PAINFUL TO TOLERATE. THE MFR'S REP CAME TO THE HOSP AND WAS ABLE TO TURN DOWN THE STIMULATION. THE PT HAS EXCHANGED THE PROGRAMMER AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY EZ PATIENT PROGRAMMER LGW MEDTRONIC INC. 7435 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED| EXPLANTED| LEAD MODEL 3487A LOT # J0455404V IMPLANTED| LOT # NFE144164H IMPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7427| EXPLANTED| LEAD MODEL 2487A LOT # J0454747V IMPLANTED