BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24501219 · Received March 3, 2026

    Report

    Report Number
    3017191859-2026-00006
    Event Type
    Injury
    Date Received
    March 3, 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

    Additional Manufacturer Narrative · 0

    UPDATE TO SECTIONS B5 AND G3.

    Description of Event or Problem · 0

    DURING A GENIO SYSTEM ACTIVATION, THE NYXOAH FIELD CLINICAL ENGINEER DISCOVERED INFORMATION FROM ONE OF THE PATIENT'S REPORTS THAT THE PATIENT HAD EXPERIENCED A POST OP HEMATOMA NEAR THE IMPLANTABLE STIMULATOR SITE RESULTING IN AN ADDITIONAL SURGICAL PROCEDURE. ACCORDING TO THE PHYSICIAN, THE HEMATOMA WAS LOCATED ANTERIOR TO THE MYLOHYOID MUSCLE, WHICH PREVENTED BLOOD FROM REACHING THE IMPLANTED SITE. THE DATE OF THE SURGERY REMAINS UNKNOWN. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES. IT IS IMPORTANT TO NOTE THIS DEVICE IS NOT DISTRIBUTED IN THE US.

    Description of Event or Problem · 0

    DURING A GENIO SYSTEM ACTIVATION, THE NYXOAH FIELD CLINICAL ENGINEER DISCOVERED INFORMATION FROM ONE OF THE PATIENT'S REPORTS THAT THE PATIENT HAD EXPERIENCED A POST OP HEMATOMA NEAR THE IMPLANTABLE STIMULATOR SITE RESULTING IN AN ADDITIONAL SURGICAL PROCEDURE. ACCORDING TO THE PHYSICIAN, THE HEMATOMA WAS LOCATED ANTERIOR TO THE MYLOHYOID MUSCLE, WHICH PREVENTED BLOOD FROM REACHING THE IMPLANTED SITE. THE DATE OF THE SURGERY REMAINS UNKNOWN.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
    554084 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H