BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1944297 · Received December 6, 2010

    Report

    Report Number
    3004209178-2010-10224
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 26, 2010
    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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SINCE EARLY FALL, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT; THE PT COULDN'T FEEL STIMULATION UNLESS SHE WAS LYING DOWN. THE PT WAS SUPPOSED TO GET PAIN RELIEF FOR HER LOWER BACK, BUT COULD ONLY FEEL STIMULATION IN HER LEG IF THE STIMULATION WAS SET HIGH. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L 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 71 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE121794N| EXPLANTED:| LEAD: MODEL 3777, LOT# V192802027| LEAD: MODEL 3777, LOT# V192802024| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA122795N