BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPOGLOSSAL NERVE STIMULUS

    MDR report key: 23759480 · Received December 9, 2025

    Report

    Report Number
    MW5180198
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 4, 2025
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INSPIRE MEDICAL SYSTEMS, HYPOGLOSSAL NERVE STIMULATION LEAD/WIRE EXTRUDED FROM SKIN ON RIGHT SIDE OF NECK. HE HAD A REVISION SURGERY FOR THE SAME ISSUE (STIMULATION LEAD/WIRE EXTRUDING FROM SKIN OF NECK) ON (B)(6) 2025. THE LEAD/WIRE WAS STITCHED DEEPER INTO MUSCLE/TISSUE. PT CODE: 2462. DEVICE CODE: 4003. REF REPORT: MW5180199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2885237 HYPOGLOSSAL NERVE STIMULUS STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC. 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention