BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO 2.1 SYSTEM

    MDR report key: 25232999 · Received May 20, 2026

    Report

    Report Number
    3017191859-2026-00015
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 20, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED FOR FOLLOW-UP AFTER ACTIVATION OF THE STIMULATION DEVICE AND REPORTED MILD LEFT-SIDED JAW PAIN AS WELL AS MILD SWALLOWING DIFFICULTIES FOLLOWING THE SURGICAL PROCEDURE. DEVICE FUNCTION WAS ASSESSED AND DEMONSTRATED APPROPRIATE STIMULATION WITH A CLEAR, STRAIGHT TONGUE PROTRUSION. THE PATIENT ADDITIONALLY REPORTED A FRACTURED DENTAL BRIDGE ON THE LEFT SIDE. A TITRATION PAUSE OF FOUR WEEKS WAS RECOMMENDED. AT SUBSEQUENT FOLLOW-UP AFTER COMPLETION OF THE PAUSE PERIOD, THE PATIENT STATED THAT THE TREATING DENTIST DID NOT CONSIDER THE JAW PAIN TO BE RELATED TO THE DENTAL BRIDGE. FURTHER DIAGNOSTIC EVALUATION, INCLUDING COMPUTED TOMOGRAPHY (CT) IMAGING AND ULTRASOUND EXAMINATION, REVEALED NO PATHOLOGICAL FINDINGS. THE PATIENT ALSO COMPLETED A TWO-WEEK COURSE OF ANTIBIOTIC THERAPY. OVERALL, THE ORIGIN OF THE PAIN REMAINS UNCLEAR. THE PATIENT WAS ADVISED TO PROCEED WITH LYMPHATIC DRAINAGE THERAPY, CONTINUE STANDARD AC STIMULATION, AND RETURN FOR CONTINUED FOLLOW-UP EVALUATION OVER THE NEXT TWO TO THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557005 GENIO 2.1 SYSTEM GENIO 2.1 SYSTEM MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1