BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 2003754 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01405
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 26, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALTHOUGH THE TRIAL STIMULATION WAS OK, THE PATIENT EXPERIENCED UNWANTED STIMULATION WITH THE PERMANENT IMPLANT. HE FELT OVERSTIMULATION. HE WOULD SET THE STIMULATION INTENSITY TO WHERE HE COULD BARELY FEEL IT, BUT WHEN HE STOOD UP, HE WOULD FEEL A SURGE IN HIS LEG. THE PATIENT'S BACK WAS THE STIMULATION TARGET. WHEN HE TURNED CERTAIN WAYS, HE FELT UNCOMFORTABLE SENSATION IN HIS TESTICLES, INNER THIGH, BACK OF LEGS, AND ANKLES. THE NEUROSTIMULATOR WAS IMPLANTED IN HIS RIGHT BUTTOCK AND FELT LIKE SOMETHING VERY SHARP WAS IN THE DEVICE POCKET. THE PATIENT EXPERIENCED NAUSEA, DIZZINESS, AND HEADACHES SINCE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR. THE PATIENT WAS IN CLOSE CONTACT WITH HIS HCP. THE DEVICE WAS REPROGRAMMED SEVERAL TIMES. THE STIMULATION DURING REPROGRAMMING WAS PAINFUL. THE IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING FINE AFTERWARD. THE SURGICAL WOUND LOOKED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3778, LOT# V544702009| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE158736N| EXPLANTED:| LEAD: MODEL 3778, LOT# V544702008