BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1202076 · Received October 16, 2008

    Report

    Report Number
    3004209178-2008-06610
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN IRRITATING BURNING SENSATION AT THE NEUROSTIMULATOR POCKET. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS TURNING ON AND OFF. THE PATENT WAS AT HOME AT THE TIME OF THE REPORT. ON/OFF OPTIONS WERE DISCUSSED, UNTIL THE DEVICE COULD BE CHECKED BY AN HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MPROC, JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR PROGRAMMER: MODEL 37742| EXTENSION: MODEL 37083| EXTENSION: MODEL 37083| RECHARGER: MODEL 37752| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3998| EXPLANTED:| EXPLANTED: