BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1191179 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-06149
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT FELL AND FELT NO STIMULATION AFTERWARD. THE PT WENT TO THE EMERGENCY ROOM WHERE X-RAYS WERE TAKEN. HE WAS DISCHARGED FROM THE EMERGENCY ROOM AND WAS TOLD THAT THERE MAY BE A 'LEAD ISSUE'. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742| ACCESSORY: MODEL 37752| LEAD: MODEL 377745| IMPLANTED:| LEAD: MODEL 3998