BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO 2.1 SYSTEM

    MDR report key: 25128147 · Received May 8, 2026

    Report

    Report Number
    3017191859-2026-00013
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 8, 2026
    Manufacturer
    NYXOAH SA
    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 WAS EXPERIENCING WORSENING OBSTRUCTIVE SLEEP APNEA. AT THE TIME OF ACTIVATION THE TONGUE PROTRUSION WAS ACCEPTABLE, BUT DETERIORATED OVER TIME. DESPITE TROUBLESHOOTING AND PARAMETER ADJUSTMENTS THE TREATING PHYSICIAN AND PATIENT DECIDED A REVISION SURGERY WAS APPROPRIATE. THE PATIENT RECEIVED THE SUCCESSFUL REVISION SURGERY (B)(6) 2026. THE DEVICE REMAINS INTACT AND WITH REPOSITIONING, THE PATIENT'S TONGUE PROTRUSION WAS RESTORED AT THE SAME SETTINGS THE PATIENT USED PRIOR TO THE REVISION SURGERY. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605046 GENIO 2.1 SYSTEM GENIO 2.1 SYSTEM MNQ NYXOAH SA

    Patients

    Seq Age Sex Outcome Treatment
    1