BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1993787 · Received January 13, 2011

    Report

    Report Number
    3007566237-2011-00365
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    THE PT RECEIVED ANOTHER IMPLANT IN NOVEMBER OR (B)(6) 2010. ABOUT 5 WEEKS LATER SHE LOST STIMULATION SENSATION. IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS POSSIBLE TO OBTAIN STIMULATION AT HIGHER AMPLITUDES BUT IT WAS IN THE WRONG LOCATION. IT WAS PLANNED TO OBTAIN X-RAYS TO DETERMINE IF LEAD MIGRATION OCCURRED. IT WAS UNCLEAR AT THE TIME OF THIS REPORT IF THE PT RECEIVED A REPLACEMENT IPG, WHOLE REPLACEMENT DEVICE SYSTEM, OR A SECOND ACTIVE DEVICE SYSTEM. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR LEAD: MODEL 3777, LOT# V173899034| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V184703032| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711| LOT# NJH719220H| PROGRAMMER: MODEL 37743, LOT# NKE121253N| ACCESSORY: MODEL 37752, LOT# NKA121373N| IMPLANTED:| IMPLANTED: