BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 24769633 · Received April 2, 2026

    Report

    Report Number
    MW5186340
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    September 11, 2025
    Report Date
    March 30, 2026
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INSPIRE IMPLANT MODEL 3028, (B)(6), IMPLANT (B)(6) 2024. INITIATED (B)(6) 2024. HAD ISSUES WITH RIGHT EAR, JAW PAIN, STIMULATOR, CHANGING FREQUENCIES ON ITS OWN, COULD NEVER GET IT TO WORK PROPERLY FOR ANY LENGTH OF TIME, DEVICE IS ALSO ROTATED AND OUT OF PLACE IN CHEST CAUSING PAIN. DISCONTINUED USE (B)(6) 2025 PER DOCTORS OFFICE. SCHEDULED FOR REVISION SURGERY ON (B)(6) 2025 BUT WAS ESCORTED OUT THE BACK DOOR OF HOSPITAL BECAUSE WE DISAGREED ABOUT WHO WAS PAYING, EVEN THOUGH AT THAT TIME, MY OUT OF POCKET HAD BEEN MET. CURRENTLY UNDER ANOTHER DOCTORS CARE, UNIT FOUND TO HAVE A SHARK FIN DISCONTINUITY (B)(6) 2025 PER INSPIRE REPORTING AND OSH DOCUMENTATION. AWAITING EXPLANT VIA (B)(6). DEVICE IS ALSO INTERFERING WITH MY MS AS I CAN NOW NO LONGER OBTAIN AN MRI BECAUSE OF THE DEFECTIVE UNIT. WHICH IS MAKING LIFE INCREDIBLY DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211965 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC. 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female EMAGALITY| KEPPRA| KESIMPTA| KLONOPIN| MULTI VITAMIN| NURTEC| PERCOCET| PRE, PRO, POST BIOTIC| SYSTANE | TRULANCE| VYVANSE