BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2081307 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02999
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 1, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NO STIMULATION SENSATION. THREE DAYS AFTER IMPLANT, WHILE GOING TO BED, THE PT FELT NO STIMULATION. THERE WERE NO FALLS OR TRAUMA TO THE AREA. THE PT WAS SEEN AT THE CLINIC AND SEVERAL ELECTRODES HAD LOW IMPEDANCES; UNDER 250 OHMS. AN X-RAY WAS RECOMMENDED, ALONG WITH REPROGRAMMING. ADD'L INFO 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 39 YR PROGRAMMER: MODEL 37743, LOT# NKE156714N| ACCESSORY: MODEL 37752, LOT# NKA145905N| LEAD: MODEL 3778, LOT# V650988037| IMPLANTED:| LEAD: MODEL 3778, LOT# V650988036| IMPLANTED:| EXPLANTED:| EXPLANTED: