BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE IMPLANT

    MDR report key: 23671090 · Received November 28, 2025

    Report

    Report Number
    MW5179441
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Report Date
    October 29, 2025
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT SAID THAT HAD A SURGERY ABOUT A MONTH AGO, SAID THAT THEY PUT A BATTERY IN THEIR CHEST AND CONTINUES TO HAVE A HARD TIME ADJUSTING TO IT. PATIENT SAID IT IS THE INSPIRE IMPLANT. WHEN ASKED, PATIENT SAID THAT ABOUT TWO DAYS AGO STARTED A NEW MEDICATION, TO CALM DOWN THEIR ANXIETY RELATED TO PREVIOUS INSPIRE IMPLANT SURGERY. 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
    2080481 INSPIRE IMPLANT STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown