BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXWAVE

    MDR report key: 24085715 · Received January 15, 2026

    Report

    Report Number
    3000214920-2026-00002
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 22, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    LIH
    UDI-DI
    00852670007007
    PMA / PMN Number
    K111279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE INITIALLY FILED THIS MDR THROUGH ESUBMITTER BUT FAILED TO COMPLETE THE SUBMISSION VIA ESG. THIS WAS DISCOVERED DURING AN AUDIT. AT THAT POINT, WE DISCOVERED THE ESG PORTAL WASN'T PROPERLY SET UP FOR ZYNEX MEDICAL, INC. WHILE UPDATING ESUBMITTER, WE LEARNED THAT THE ESUBMITTER PROGRAM NEEDED TO BE UPDATED. WHILE UPDATING THE ESUBMITTER PROGRAM, WE DISCOVERED A BUG IN THE PROGRAM THAT WOULDN'T ALLOW THE COMPLETION OF THE SUBMISSION. A TICKET WAS INITIATED AND SUBMITTED TO BOTH CESUB HELP DESK AND THE ESGNG SUPPORT EMAIL LINKS ON NOVEMBER 3, 2025, NOVEMBER 10, 2025, NOVEMBER 18, 2025, NOVEMBER 19, 2025, THE FIRST RESPONSE WE RECEIVED FOR SUPPORT WAS ON 12/3/2025, WHICH DIRECTED US TO UNINSTALL/REINSTALL THE SOFTWARE, WHICH WE DID TWICE, WITH NO RESOLUTION. WE THEN ATTEMPTED TO INSTALL THE SOFTWARE ON A COMPLETELY DIFFERENT COMPUTER, WHICH FAILED TO RESOLVE THE ISSUE AS WELL. I THEN SUBMITTED ADDITIONAL HELP DESK TICKETS TO THE ESUBMITTER, CDRHESUB, AND EMDR SUPPORT LINKS ON 12/9/2025. ON 12/11/2025, I RECEIVED AN ACKNOWLEDGEMENT FROM THE ESUBMITTER HELP DESK THAT THEY DISCOVERED AN ISSUE WITH THE PROGRAM AND WOULD RESPOND WHEN RESOLVED. ON 12/29/2025, WE RECEIVED A SOLUTION AND DIRECTIONS FOR FIXING THE SOFTWARE BUG, WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE PATIENT WAS AT A CLINIC AND THE ELECTRODES WERE PLACED AROUND HIS KNEE CAP TO SHOW THE PATIENT HOW TO USE THE DEVICE AND WHEN THE DEVICE WAS TURNED TO 3MA ON IFC THE PATIENT LOST CONCIOUSNESS FOR APPROXIMATELY ONE MINUTE. THE CLINIC IMMEDIATELY REMOVED THE DEVICE AND NOTIFIED THE TERRITORY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141951 NEXWAVE NEXWAVE LIH ZYNEX MEDICAL, INC. 800400 1317777 00852670007007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other