BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 18606972 · Received January 29, 2024

    Report

    Report Number
    MW5150873
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Report Date
    January 25, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WOULD LIKE TO ADVISE THE FDA ABOUT ISSUES WITH THE INSPIRE SLEEP-APNEA DEVICE. IT DID NOT WORK FOR ME AND I DON'T THINK IT DOES FOR MANY PEOPLE DESPITE THE HYPE ON THEIR WEBSITE. I THINK THE APPROVAL OF THIS DEVICE SHOULD BE REVISITED. ALSO, THEY DO NOT DISCLOSE THAT THIS DEVICE "PULSES" THE MAJORITY OF THE NIGHT - NOT JUST WHEN YOU ARE EXPERIENCING APNEA. IT IS UNCOMFORTABLE TO SAY THE LEAST. THE COST TO IMPLANT IS EXCESSIVE. THE TIME AND COST FOR PRE- AND POST APPOINTMENTS ARE ALSO EXCESSIVE. THERE ARE SO MANY ISSUES, I CAN'T BELIEVE PEOPLE ARE STILL LINING UP TO GET THIS. THEY NEED TO BE TOLD THE TRUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251086 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. AIR347271C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female