BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24474377 · Received February 27, 2026

    Report

    Report Number
    3017191859-2026-00005
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 23, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTIONS B5 AND D4. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 0

    A PATIENT WAS IMPLANTED ON (B)(6) 2025 WITH THE LEGACY GENIO IMPLANTABLE STIMULATOR (NOT PN 2954) AND UPON ACTIVATION, THERE WAS NO STIMULATION. ON (B)(6) 2026 THE PATIENT UNDERWENT A REPLACEMENT SURGERY. SURGICALLY REACHING THE IMPLANTABLE STIMULATOR WAS CHALLENGED BY FIBROTIC TISSUE. ALL RELATED IMPLANTABLE STIMULATOR STRUCTURES WERE ENCAPSULATED. THE IMPLANTABLE STIMULATOR WAS SUCCESSFULLY REPLACED WITH A NEW DEVICE. TESTING OF THE DEVICE BOTH BEFORE AND AFTER SKIN CLOSURE PRODUCED ACCEPTABLE STRAIGHT TONGUE PROTRUSION.

    Description of Event or Problem · 0

    A PATIENT WAS IMPLANTED ON (B)(6) 2025 WITH THE LEGACY GENIO IMPLANTABLE STIMULATOR (NOT PN 2954) AND UPON ACTIVATION, THERE WAS NO STIMULATION. ON (B)(6) 2026 THE PATIENT UNDERWENT A REPLACEMENT SURGERY. SURGICALLY REACHING THE IMPLANTABLE STIMULATOR WAS CHALLENGED BY FIBROTIC TISSUE. ALL RELATED IMPLANTABLE STIMULATOR STRUCTURES WERE ENCAPSULATED. THE IMPLANTABLE STIMULATOR WAS SUCCESSFULLY REPLACED WITH A NEW DEVICE. TESTING OF THE DEVICE BOTH BEFORE AND AFTER SKIN CLOSURE PRODUCED ACCEPTABLE STRAIGHT TONGUE PROTRUSION. 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
    529748 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other