BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1840072 · Received September 15, 2010

    Report

    Report Number
    3004209178-2010-07009
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001/S74
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PT WAS INVOLVED IN A VEHICLE ACCIDENT IN JUNE (IN A TRUCK THAT ROLLED SEVERAL TIMES) AND SINCE THEN, SHE WAS CHARGING MORE THAN EXPECTED. IMPEDANCE VALUES INDICATED SEVERAL OPEN CIRCUITS. IT WAS POSSIBLE TO GET THE PT SOME STIMULATION BUT NOT FULL COVERAGE. THE INS WAS HOLDING CHARGE FOR ABOUT A DAY AT A TIME. THE PT WAS SCHEDULED FOR REPLACEMENT (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA011137N| PROGRAMMER: MODEL 37742, LOT# NJD014480N| LEAD: MODEL 3777, LOT# N0033267