BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1981403 · Received February 1, 2011

    Report

    Report Number
    3007566237-2011-00788
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFO WAS RECEIVED WHICH STATED THE PT FELT AN OVERSTIMULATION SENSATION WHETHER THE STIMULATION WAS ON OR OFF. THIS OCCURRED FOLLOWING A POSITION CHANGE. PT SAID SHE FEELS STIMULATION THROUGHOUT HER ENTIRE BODY. THE DEVICE IS CURRENTLY TURNED OFF AND PT IS STILL FEELING STIMULATION. PT WAS ALSO HAVING SOME DIFFICULTY OPERATING HER PT PROGRAMMER AND MEDTRONIC TECHNICAL SERVICES WAS ABLE TO REVIEW BASIC FUNCTIONALITY WITH HER. PT WAS SEEN BY THE MEDTRONIC REP AT THE IMPLANTING PHYSICIAN'S OFFICE. HE REVIEWED AND RE-EDUCATED THE PT ON THE PT PROGRAMMER AND RECHARGER COMPONENTS. PT WAS DOING FINE AND DID NOT REQUEST ANY REPROGRAMMING AT THIS POINT. ADDITIONAL 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 MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| ACCESSORY: MODEL 37752, LOT# UNK| EXPLANTED:| LEAD: MODEL 38565-65, LOT# UNK| PROGRAMMER: MODEL 37743, LOT# UNK