BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE SLEEP APNEA DEVICE

    MDR report key: 22898021 · Received August 26, 2025

    Report

    Report Number
    MW5175257
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Report Date
    August 15, 2025
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT MENTIONED THEY HAVE A SLEEP APNEA DEVICE IMPLANT FROM INSPIRE THAT NEEDS REPROGRAMMING AND NEED TO CONTACT THEM. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. "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
    1380377 INSPIRE SLEEP APNEA DEVICE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown