BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MT ELECTRODE & TUBES

    MDR report key: 10676753 · Received October 14, 2020

    Report

    Report Number
    3002250546-2020-00004
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 5, 2020
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    UDI-DI
    10873263007508
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ADVERSE EVENT INVOLVING FHC MT ELECTRODE & TUBES OCCURRED DURING A CASE ON (B)(6) 2020. THE EVENT WAS DESCRIBED AS FOLLOWS: AFTER SINGLE PASS MER THE SURGEON ADVANCED THE MICROELECTRODE TO THE VIM TARGET AND THE PATIENT BEGAN TO SLUR HIS SPEECH. THERE WAS NO STIMULATION RUNNING AT THE TIME. HCPS DECIDED TO DISCONTINUE WITH PLAN TO TEST STIM AND REMOVED THE MICRO ELECTRODE AND IMPLANTED A 3387. THE ISSUE WAS NOT WITH THE DEVICE, IT WAS JUST THE DEVICE THAT WAS BEING USED AT THE TIME THE ISSUE OCCURRED. PATIENT WAS CONSCIOUS AND ABLE TO TALK, BUT HAD SLURRED SPEECH A THE END OF THE PROCEDURE. POSSIBLE STUN EFFECT. PATIENT UPDATE: THE PATIENT STILL HAS SLIGHTLY SLURRED SPEECH BUT IS IMPROVING. THIS HAS BEEN CONFIRMED WITH THE PHYSICIAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140383 MT ELECTRODE & TUBES DEPTH ELECTRODE GZL FHC, INC. FC2002 244446 10873263007508

    Patients

    Seq Age Sex Outcome Treatment
    1 Other