BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2081266 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02962
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATOR WAS TURNING OFF ON ITS OWN. WHEN THE DEVICE WAS TURNED ON, THE VOLTAGE WAS NOTED AT 0.30 VOLTS BUT WHEN SHE INCREASED THE STIMULATION, THE MESSAGE ON THE SCREEN OF THE PATIENT PROGRAMMER DISPLAYED "TURN STIM ON." ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA144373N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154088N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V522460003