BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1981626 · Received January 31, 2011

    Report

    Report Number
    3004209178-2011-00750
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Report Date
    January 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD PAIN IN HIS BACK, HE COULDN'T LIE ON HIS SIDE AND IT WAS DIFFICULT TO SLEEP. IT WAS STATED THAT "TWO ELECTRODES WERE ON HIS SPINE". THE PT WANTED THE DEVICE REMOVED AS HIS PHYSICIAN INFORMED HIM IT "MIGHT BE SHORTING OUT". FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    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 EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD021818N| ACCESSORY: MODEL 37752, LOT# NKA016978N| IMPLANTED:| LEAD: MODEL 3777, LOT# N0030760| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# N0041364