BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA

    MDR report key: 23606069 · Received November 20, 2025

    Report

    Report Number
    MW5179165
    Event Type
    Injury
    Date Received
    November 20, 2025
    Report Date
    November 18, 2025
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CALLER ALSO MENTIONED THAT THEY HAVE ANOTHER IMPLANT CALLED INSPIRE AND SO THEY KNOW WHAT THE FLUTTERING FEELS LIKE BECAUSE THEY CAN FEEL IT IN THEIR TONGUE. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076991 STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown