BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2031339 · Received March 16, 2011

    Report

    Report Number
    3004209178-2011-02002
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    March 2, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION AND SHE COULD NOT TURN THE INS OFF. THE INS WAS STICKING OUT OF THE PT'S RIGHT SIDE AND THERE WAS A BROKEN WIRE FROM WHEN THE INS WAS IMPLANTED THAT WAS NEVER FIXED. THE OUTCOME IS UNK. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD021207N| LEAD: MODEL 3487A, LOT# J0118292V| EXTENSION: MODEL 7495-51, LOT# XR0005455V| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000847N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# L69130| ACCESSORY: MODEL 37752, LOT# NKA016577N| EXPLANTED:| EXPLANTED: