BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1203506 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06654
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT LOST STIMULATION WHILE OUT FOR A WALK. THE PT MET WITH THE MANUFACTURER REP AT THE CLINIC. THE PT HAD VERY SLIGHT STIMULATION USING ELECTRODE 5,6 AND 7 WITH THE VOLTAGE UP TO 10.5 VOLTS. IMPEDANCE READINGS>3600 OHMS AND 3000 WAS REPORTED ON ELECTRODES 5, 6 AND 7. AN X-RAY OF THE LEAD AND /OR EXTENSION WAS RECOMMENDED.

    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 63 YR PROGRAMMER: MODEL 37742| RECHARGER SYSTEM: MODEL 37752| IMPLANTED:| LEAD: MODEL 3999| EXPLANTED:| LEAD: MODEL 3999| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082| IMPLANTED: