BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24589724 · Received March 13, 2026

    Report

    Report Number
    3017191859-2026-00008
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 13, 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

    ON (B)(6) 2026, THE PATIENT WAS SEEN BY NYXOAH STAFF AT THE CLINIC FOR ACTIVATION, WHERE IT WAS OBSERVED TONGUE RETRACTION ON THE LEFT SIDE AND NO STIMULATION (RESPONSE) ON THE RIGHT SIDE. ON (B)(6) 2026, THE PATIENT HAD A REVISION SURGERY. IT IS UNCLEAR AT THIS TIME IF THE ORIGINAL IMPLANTABLE STIMULATOR WAS ADJUSTED FOR THE REVISION OR IF A NEW IMPLANTABLE STIMULATOR WAS IMPLANTED. 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
    658356 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other