BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2021747 · Received February 25, 2011

    Report

    Report Number
    3004209178-2011-01461
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT'S BACK WAS HURTING "LIKE IT WAS ON FIRE". PT WENT TO PHYSIOTHERAPIST AND DID SOME EXERCISES WHILE LYING DOWN, PT COULD NOT SIT BUT COULD LAY ON THEIR SIDE. AFTER EXERCISES THE DEVICE WAS AT 0.00, TURNED ON THE STIMULATION AND STIMULATION WAS IN BOTH LEGS AND SHOULD ONLY BE IN THE RIGHT LEG. PT IS WAITING FOR AN APPOINTMENT TO SEE THEIR HCP. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A F/U REPORT WILL BE SENT.

    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 IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB073772V| EXPLANTED:| LEAD: MODEL 39565-30, LOT# 0203277106| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE142786N| EXTENSION: MODEL 37081, LOT# NJB074401V| EXPLANTED:| IMPLANTED: