BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2040880 · Received March 18, 2011

    Report

    Report Number
    3007566237-2011-02092
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    December 1, 2010
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 IMPLANTABLE NEUROSTIMULATOR DELIVERED STIMULATION USING 14 ELECTRODES, AT A PULSE WIDTH OF 450-600 MICROSECONDS, A RATE OF 65-100 HERTZ, AND AT 4.5 VOLTS. THE PT HAD 2 GROUPS WITH 2 PROGRAMS EACH. THE IMPLANTABLE NEUROSTIMULATOR STARTED DISPLAYING OUT OF REGULATION MESSAGES ABOUT 4 MONTHS AGO. THE PT HAD THE ABILITY TO ADJUST STIMULATION WITH HER PT PROGRAMMER. STIMULATION PARAMETERS WERE DECREASED TO DELIVER STIMULATION USING 3 ELECTRODES PER LEAD. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 NA Female EXPLANTED:| IMPLANTED:| LEAD: MODEL AND LOT# UNKNOWN| IMPLANTED:| LEAD: MODEL AND LOT# UNKNOWN| EXPLANTED: