BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO 2.1 SYSTEM

    MDR report key: 25152576 · Received May 12, 2026

    Report

    Report Number
    3017191859-2026-00014
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 12, 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 EXPERIENCED INCONSISTENT STIMULATION STARTING MARCH 18, 2026. TROUBLESHOOTING EFFORTS, INCLUDING PARAMETER CHANGES AND THE USE OF DIFFERENT DEVICES, RESULTED IN THE SAME INCONSISTENT STIMULATION. THIS ISSUE WAS CONFIRMED DURING SLEEP STUDIES AND WAKEFUL TITRATION. THE PATIENT EXITED THE STUDY AND OPTED TO HAVE THE DEVICE EXPLANTED. NO ADDITIONAL INFORMATION FOR THIS PATIENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546783 GENIO 2.1 SYSTEM GENIO 2.1 SYSTEM MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1