BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24337772 · Received February 13, 2026

    Report

    Report Number
    3017191859-2026-00002
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 18, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES TO SECTIONS B4, B5, D4, E1, G1, H4, H5.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT PRESENTED TO THE TREATING HOSPITAL FOR A SCHEDULED TITRATION VISIT AND REPORTED THAT FOR THE PAST TWO DAYS, HE HAD NOT BEEN FEELING THE CONFIRMATORY PULSE WHEN INITIATING THERAPY. TROUBLESHOOTING WAS PERFORMED BY THE FIELD CLINICAL ENGINEER AND IS AS FOLLOWS: THE ACTIVATION CHIP WAS INSPECTED AND DID NOT APPEAR TO HAVE ANY ABNORMALITIES. A NEW DISPOSABLE PATCH MAPPING WAS PERFORMED IN AN ATTEMPT TO IDENTIFY AN OPTIMAL LOCATION FOR THE PATCH AND ACTIVATION CHIP. THE FIELD CLINICAL ENGINEER THEN ATTEMPTED TO ADJUST THE ACTIVATION CHIP PARAMETERS IN ORDER TO IDENTIFY OPTIMAL SETTINGS FOR APPROPRIATE THERAPY, HOWEVER OPTIMAL STABLE SETTINGS COULD NOT BE IDENTIFIED. X-RAYS WERE TAKEN, BUT DUE TO THE DIFFERENCES IN HEAD POSITION BETWEEN THE INITIAL POST OP X-RAY AND THE ONE TAKE FOR THIS ISSUE, ANY MOVEMENT OF THE IMPLANT COULD NOT BE DETERMINED. IT WAS NOTED, THAT THERE WAS AN INCREASE IN SUBMENTAL SKIN LAXITY COMPARED TO PREVIOUS IMAGING. THE PATIENT WAS INSTRUCTED TO NOT CONTINUE THERAPY UNTIL INSTRUCTED TO DO SO. ON (B)(6) 2026 IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED, HOWEVER, THE DEVICE WAS INSTEAD EXPLANTED BECAUSE ADDITIONAL CRANIAL SPACE WAS NEEDED AND NOT AVAILABLE. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT PRESENTED TO THE TREATING HOSPITAL FOR A SCHEDULED TITRATION VISIT AND REPORTED THAT FOR THE PAST TWO DAYS, HE HAD NOT BEEN FEELING THE CONFIRMATORY PULSE WHEN INITIATING THERAPY. TROUBLESHOOTING WAS PERFORMED BY THE FIELD CLINICAL ENGINEER AND IS AS FOLLOWS: THE ACTIVATION CHIP WAS INSPECTED AND DID NOT APPEAR TO HAVE ANY ABNORMALITIES. A NEW DISPOSABLE PATCH MAPPING WAS PERFORMED IN AN ATTEMPT TO IDENTIFY AN OPTIMAL LOCATION FOR THE PATCH AND ACTIVATION CHIP. THE FIELD CLINICAL ENGINEER THEN ATTEMPTED TO ADJUST THE ACTIVATION CHIP PARAMETERS IN ORDER TO IDENTIFY OPTIMAL SETTINGS FOR APPROPRIATE THERAPY, HOWEVER OPTIMAL STABLE SETTINGS COULD NOT BE IDENTIFIED. X-RAYS WERE TAKEN, BUT DUE TO THE DIFFERENCES IN HEAD POSITION BETWEEN THE INITIAL POST OP X-RAY AND THE ONE TAKE FOR THIS ISSUE, ANY MOVEMENT OF THE IMPLANT COULD NOT BE DETERMINED. IT WAS NOTED THAT THERE WAS AN INCREASE IN SUBMENTAL SKIN LAXITY COMPARED TO PREVIOUS IMAGING. THE PATIENT WAS INSTRUCTED TO NOT CONTINUE THERAPY UNTIL INSTRUCTED TO DO SO. ON (B)(6) 2026 IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED, HOWEVER, THE DEVICE WAS INSTEAD EXPLANTED BECAUSE ADDITIONAL CRANIAL SPACE WAS NEEDED AND NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17795 GENIO IS GENIO IS MNQ NYXOAH S.A. GENIO SYSTEM 2.1

    Patients

    Seq Age Sex Outcome Treatment
    1