BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 1923170 · Received November 9, 2010

    Report

    Report Number
    3007566237-2010-09098
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 19, 2010
    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

    IT WAS REPORTED THE STIMULATION COULD NOT BE ADJUSTED, AND THERE WAS A POWER-ON RESET (POR) CONDITION. THE DEVICE WAS DISPLAYING THE "CALL YOUR DOCTOR" ICON. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MEDTRONIC NEUROMODULATION 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1