BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE SLEEP APNEA IMPLANT

    MDR report key: 24033465 · Received January 12, 2026

    Report

    Report Number
    MW5182015
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    January 16, 2025
    Report Date
    January 5, 2026
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE FLYING ON AN EXTENDED FLIGHT (16 HOURS), I TURNED MY INSPIRE SLEEP APNEA DEVICE ON TO SLEEP. AFTER A FEW MINUTES, I HAD A BURNING SENSATION IN MY CHEST NEAR THE BATTERY. IT STOPPED AFTER I TURNED THE DEVICE ON. I REPEATED THIS TRIAL A FEW TIMES WHILE ON THIS FLIGHT AND HAD THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107606 INSPIRE SLEEP APNEA IMPLANT STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other B VITAMIN.| GABAPENTIN 200 MG TWICE A DAY.| L-METHYLFOLATE 15 MG.| LAMOTRIGINE 100 MG.| LO-LOESTRIN FE.| NALTREXONE 4.5 MG.| NORTRIPTYLINE 10 MG. | REXULTI .5 MG.| VILAZODONE 40 MG.