BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXWAVE

    MDR report key: 24021779 · Received January 9, 2026

    Report

    Report Number
    3000214920-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    March 12, 2024
    Report Date
    January 8, 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

    THIS RECORD WAS DISCOVERED AS PART OF A HISTORICAL REVIEW OF DATA. ONCE IT WAS DISCOVERED THAT IT WAS REPORTABLE, WE INITIATED THE MDR. THE FILE WAS COMPILED IN THE ESUBMITTER PROGRAM BUT WAS NEVER SUBMITTED VIA ESG UNTIL IT WAS DISCOVERED AS PART OF 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 CESUBHELPDESK AND THE ESGNGSUPPORT SUPPORT EMAIL LINKS ON (B)(6) 2025, THE FIRST RESPONSE WE RECEIVED FOR SUPPORT WAS ON (B)(6) 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 (B)(6)2025. ON (B)(6) 2025, I RECEIVED AN ACKNOWLEDGEMENT FROM THE ESUBMITTER HELP DESK THAT THEY DISCOVERED AN ISSUE WITH THE PROGRAM AND WOULD RESPOND WHEN RESOLVED. ON (B)(6) 2025, WE RECEIVED A SOLUTION AND DIRECTIONS FOR FIXING THE SOFTWARE BUG, WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED THERAPY ON THEIR SHOULDER AFTER SURGERY. IT WAS STATED BY THE SURGEON THAT THE PATIENT'S PULSE WAS 20% BELOW NORMAL AND BOTH POTASSIUM AND MAGNESIUM LEVELS WERE LOW PRIOR TO TREATMENT WITH THE DEVICE. THE TREATMENT LEVEL AT THE TIME OF THE INCIDENT WAS AT 4 MA. THE DOCTOR STATED THAT THE DEVICE POSSIBLY CAUSED BRADYCARDIA AND VASOVAGAL DUE TO CAROTID COMPRESSION BECAUSE OF THE PLACEMENT OF THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86110 NEXWAVE NEXWAVE LIH ZYNEX MEDICAL, INC 700400 1331379 00852670007007

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other