BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2180712 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05189
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 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

    IT WAS REPORTED THE PT EXPERIENCED A LACK OF STIMULATION ON THE LEFT SIDE OF THE BACK AFTER TURNING AROUND WHILE DOING DISHES. THE PT'S PAIN RETURNED AND FELT LIKE A STABBING SENSATION IN THE BACK. THE PT HAD INCREASED THE SETTING TO 7.0 OR 8.0 AND STILL DID NOT FEEL STIMULATION. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 48 YR LEAD: MODEL 3777, LOT# V658242027| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA151831N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE166270N| LEAD: MODEL 3777, LOT# V655424037| EXPLANTED:| IMPLANTED:| EXPLANTED: