BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24402355 · Received February 20, 2026

    Report

    Report Number
    3017191859-2026-00003
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 20, 2026
    Manufacturer
    NYXOAH
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONS TO SECTIONS B5, D4, E1 AND CORRECTION TO D3.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE PATIENT REPORTED NO LONGER FEELING STIMULATION. THE PATIENT WAS REFERRED TO THE CLINIC FOR A WAKEFUL TITRATION (WT) PROCEDURE. DURING THE WT THE PATIENT RESPONDED TO THE STIMULATION, BUT IT WAS BARELY NOTICEABLE OR NOT NOTICEABLE AT ALL 4-5 TIMES. ADDITIONAL TROUBLE SHOOTING WAS PERFORMED WITH VARIOUS ACTIVATION CHIPS. AN X-RAY WAS TAKEN. THE PHYSICIAN DETECTED OSSIFICATION ON THE X-RAY IMAGE. THE PATIENT THEN WAS INSTRUCTED TO CONTINUE USING THE DEVICE FOR ONE MONTH TO SEE IF THERE WAS ANY IMPROVEMENT IN STIMULATION. AFTER ONE MONTH OF CONTINUED USE, THERE WAS NO IMPROVEMENT IN STIMULATION. THE ORIGINAL IMPLANTABLE STIMULATOR, SERIAL NUMBER: (B)(6) WAS EXPLANTED DURING THE REVISION SURGERY, AS IT DEMONSTRATED NO FUNCTION WITH ADDITIONAL TESTING. DURING THE SURGERY THE PHYSICIAN REPORTED A LOT OF CALCIFICATION AND FIBROTIC TISSUE AROUND THE IMPLANT PADDLES AND A BONE STRUCTURE GOING FROM THE HYOID BONE TO THE IMPLANT. THE PHYSICIAN REMOVED THE BONE STRUCTURE AND REPLACED THE IMPLANTABLE STIMULATOR. WITH THE NEW DEVICE AND REMOVAL OF THE FIBROTIC TISSUE AROUND THE NERVES, A MODERATE STRAIGHT TONGUE PROTRUSION WAS ACHIEVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025 THE PATIENT REPORTED NO LONGER FEELING STIMULATION. THE PATIENT WAS REFERRED TO THE CLINIC FOR A WAKEFUL TITRATION (WT) PROCEDURE. DURING THE WT THE PATIENT RESPONDED TO THE STIMULATION, BUT IT WAS BARELY NOTICEABLE OR NOT NOTICEABLE AT ALL 4-5 TIMES. ADDITIONAL TROUBLE SHOOTING WAS PERFORMED WITH VARIOUS ACTIVATION CHIPS. AN X-RAY WAS TAKEN. THE PHYSICIAN DETECTED OSSIFICATION ON THE X-RAY IMAGE. THE PATIENT THEN WAS INSTRUCTED TO CONTINUE USING THE DEVICE FOR ONE MONTH TO SEE IF THERE WAS ANY IMPROVEMENT IN STIMULATION. AFTER ONE MONTH OF CONTINUED USE, THERE WAS NO IMPROVEMENT IN STIMULATION. THE ORIGINAL IMPLANTABLE STIMULATOR, SERIAL NUMBER: 2403201 WAS EXPLANTED DURING THE REVISION SURGERY, AS IT DEMONSTRATED NO FUNCTION WITH ADDITIONAL TESTING. DURING THE SURGERY THE PHYSICIAN REPORTED A LOT OF CALCIFICATION AND FIBROTIC TISSUE AROUND THE IMPLANT PADDLES AND A BONE STRUCTURE GOING FROM THE HYOID BONE TO THE IMPLANT. THE PHYSICIAN REMOVED THE BONE STRUCTURE AND REPLACED THE IMPLANTABLE STIMULATOR. WITH THE NEW DEVICE AND REMOVAL OF THE FIBROTIC TISSUE AROUND THE NERVES, A MODERATE STRAIGHT TONGUE PROTRUSION WAS ACHIEVED. IT IS IMPORTANT TO NOTE THIS DEVICE IS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460429 GENIO IS GENIO IS MNQ NYXOAH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other