BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1120765 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04980
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    May 1, 2007
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT FELT NO STIMULATION IN HIS RIGHT LEG WHEN THE SYS WAS TURNED ON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IMPEDANCES WERE GREATER THAN 3600 OHMS ON ELECTRODES 0, 1, 4, 5, 6, AND 7. IMPEDANCES ON ELECTRODES 2, 3 WERE WITHIN NORMAL LIMITS. THE PT DID NOT FEEL STIMULATION AFTER ELECTRODES 2 AND 3 WERE REPROGRAMMED. IMPEDANCES ON ELECTRODES 8-15 WERE WITHIN NORMAL LIMITS AND THE PT WAS GETTING GOOD STIMULATION COVERAGE ON THE CORRESPONDING SIDE OF HIS BODY. IT WAS LATER REPORTED THAT IMPEDANCES ON ALL 16 ELECTRODES WERE GREATER THAN 3600 OHMS. IT WAS DETERMINED THAT THE LEADS WERE FRACTURED. THE PT WASN'T USING STIMULATION THERAPY BECAUSE HE WAS GETTING SHOCKED. AS PART OF HIS JOB, THE PT WAS IN CLOSE PROXIMITY TO A WELDER. LEAD REPLACEMENT WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3777 LOT # V024394008 IMPLANTED| LEAD MODEL 3777 LOT # V024394006 IMPLANTED| EXPLANTED