BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1971016 · Received January 6, 2011

    Report

    Report Number
    3004209178-2011-00139
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 22, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO FROM MEDTRONIC REP THAT PT IS NOT RECEIVING THERAPEUTIC STIMULATION AND DEVICE IS SHOWING HIGH IMPEDANCE READINGS >3600 OHMS. PT SUFFERED TWO FALLS, ONE IN JULY AND ONE IN SEPT. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.

    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 62 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004139N| IMPLANTED:| LEAD: MODEL 3986A, LOT# N199172| PROGRAMMER: MODEL 37742, LOT# NJD046471N| ACCESSORY: MODEL 37752, LOT# NKA032772N