BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24663227 · Received March 23, 2026

    Report

    Report Number
    3017191859-2026-00010
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 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

    ON (B)(6) 2022 THE PATIENT WAS IMPLANTED WITH A GENIO IMPLANTABLE STIMULATOR. THE PATIENT'S COURSE WAS UNEVENTFUL UNTIL (B)(6) 2025 WHERE THERE WERE REPORTS OF LOSS OF STIMULATION. INVESTIGATION INTO POTENTIAL CAUSES INCLUDED TESTING WITH ADDITIONAL ACTIVATION CHIPS, AND WHEN EXTERNAL COMPONENTS WERE RULED OUT, X-RAY IMAGES WERE TAKEN. AT THE TIME NO DEFECTS WERE FOUND, AND THE POSITION OF THE IMPLANT WAS UNCHANGED FROM THE X-RAY TAKEN POST OP THE DAY OF THE IMPLANT. A DECISION WAS MADE IN (B)(6) 2025 TO REVISE THE SURGERY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2026. STIMULATION WAS TESTED IMMEDIATELY PRIOR TO THE PROCEDURE USING AN ACTIVATION CHIP/DISPOSABLE PATCH AT VARIOUS SETTINGS WHICH SHOWED NO TONGUE RESPONSE. INTRA-OPERATIVELY, AN OSSIFICATION WAS OBSERVED (BONE MATERIAL AROUND THE IMPLANT). ON THE RIGHT SIDE OF THE IMPLANT, A FRACTURE OF THE IMPLANT WING WAS NOTED. THE PROCEDURE WAS PERFORMED WITHOUT INCIDENT, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2026 WITHOUT COMPLICATION. 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
    725104 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other