BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1890980 · Received October 29, 2010

    Report

    Report Number
    3004209178-2010-08652
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION AND NOTED THAT THE UPPER LIMIT WAS REACHED. THE CALLER REPORTED INTERMITTENT STIMULATION FOLLOWING A FALL AROUND THE BEGINNING OF (B)(6). THE PT SLIPPED WHILE WALKING DOWN THE STAIRS AND GRABBED SOMETHING TO PREVENT HIS FALL. AT THE TIME OF THIS REPORT, THE PT HAD AN APPOINTMENT SCHEDULED WITH HIS HCP. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP BECOMES AVAILABLE.

    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 57 YR EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA018494N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD019722N| EXTENSION: MODEL 37083, LOT # NKC007807N| IMPLANTED:| LEAD: MODEL 3888, LOT # J0511420V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: