BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC NEUROMODULATION

    MDR report key: 8509380 · Received April 11, 2019

    Report

    Report Number
    MW5085821
    Date Received
    April 11, 2019
    Date of Event
    December 12, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    EZW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAVE A "BOLD" IN MY BACK FOR NOTHING. (B)(6), I CANNOT SLEEP WELL. THE SIDE WHERE I HAVE THE IMPLANT CAUSES ME PAIN AND SEVERELY BOTHERS, SOMETIMES FEVER, TREMOR, AND STRONG DIZZINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298049 MEDTRONIC NEUROMODULATION STIMULATOR, ELECTRICAL, IMPLANTABLE EZW MEDTRONIC 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other