BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2060952 · Received March 14, 2011

    Report

    Report Number
    3004209178-2011-01904
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS REVISED (DETAILS NOT PROVIDED). STIMULATION WAS FINE WHEN SHE WENT HOME AFTER SURGERY. OVER THE COURSE OF THE NEXT 2-3 DAYS STIMULATION MOVED FROM THE TARGET LEG TO THE OPPOSITE LEG. THE LOCAL FIELD REPS WERE NOTIFIED OF THE SITUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V364271028| PROGRAMMER: MODEL 37743, LOT# NKE157568N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA143173N| LEAD: MODEL 3776, LOT# V425023033| EXPLANTED:| IMPLANTED: