BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2030903 · Received March 4, 2011

    Report

    Report Number
    3004209178-2011-01655
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    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

    IT WAS REPORTED THE PT FELT A "SURGING SENSATION" WHEN THE STIMULATOR WAS TURNED ON. THE PT HAD FALLEN A FEW TIMES, BUT IT WAS NOT CLEAR IF THE FALLS CAUSED THE SURGING SENSATION. IT WAS ALSO REPORTED THE IMPEDANCES WERE >3600 OHMS ON COMBINATIONS WITH ELECTRODES 0 AND 4. THE PT WAS NOT PROGRAMMED WITH ELECTRODES 0 OR 4. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 75 YR EXTENSION: MODEL 37082, LOT# NKB001082N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD059753N| IMPLANTED:| LEAD: MODEL 3998, LOT# V003739| IMPLANTED:| EXPLANTED: