BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24589949 · Received March 13, 2026

    Report

    Report Number
    3017191859-2026-00009
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    February 6, 2026
    Report Date
    March 27, 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

    UPDATES TO B4, B5, D3, D4, G1

    Description of Event or Problem · 0

    THE PATIENT WAS SCHEDULED FOR ACTIVATION OF THE GENIO SYSTEM ON (B)(6) 2026. THE NYXOAH FIELD TECHNICAL ENGINEER WAS INFORMED BY THE TREATING HOSPITAL THAT THE PATIENT WILL NOT ATTEND THE VISIT BECAUSE ON (B)(6) 2026 THE PATIENT UNDERWENT SURGERY TO TREAT A SUBCUTANEOUS ABSCESS. NYXOAH WAS NOT INFORMED OF THIS EVENT UNTIL BEING CONTACTED BY THE HOSPITAL ON (B)(6) 2026, SO THE INTEGRITY OF THE IMPLANTABLE STIMULATOR COULD NOT BE ASSESSED. ACCORDING TO THE AVAILABLE INFORMATION, THE ABSCESS WAS SUBCUTANEOUS AND NO MUSCLE LAYER WAS DAMAGED OR OPENED TO DRAIN THE ABSCESS.

    Description of Event or Problem · 0

    THE PATIENT WAS SCHEDULED FOR ACTIVATION OF THE GENIO SYSTEM ON (B)(6) 2026. THE NYXOAH FIELD TECHNICAL ENGINEER WAS INFORMED BY THE TREATING HOSPITAL THAT THE PATIENT WILL NOT ATTEND THE VISIT BECAUSE ON (B)(6) 2026 THE PATIENT UNDERWENT SURGERY TO TREAT A SUBCUTANEOUS ABSCESS. NYXOAH WAS NOT INFORMED OF THIS EVENT UNTIL BEING CONTACTED BY THE HOSPITAL ON (B)(6) 2026, SO THE INTEGRITY OF THE IMPLANTABLE STIMULATOR COULD NOT BE ASSESSED. ACCORDING TO THE AVAILABLE INFORMATION, THE ABSCESS WAS SUBCUTANEOUS AND NO MUSCLE LAYER WAS DAMAGED OR OPENED TO DRAIN THE ABSCESS. 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
    495361 GENIO IS GENIO IS MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1