BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE SLEEP APNEA

    MDR report key: 19795830 · Received July 22, 2024

    Report

    Report Number
    MW5157430
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    August 18, 2020
    Report Date
    July 16, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE INSPIRE SLEEP APNEA DEVICE WAS IMPLANTED ON (B)(6) 2020, AND IT HAS NEVER PERFORMED AS INDICATED. I UNDERWENT SEVERAL ADJUSTMENTS AND SLEEP STUDIES IN AN ATTEMPT TO TITRATE THE DEVICE. THE DEVICE HAS NEVER BEEN EFFECTIVE. I WISH TO HAVE IT REMOVED AS IT IS NOT MRI COMPLIANT, AND COULD HAMPER FUTURE TREATMENTS AND TESTING. I HAVE SPOKEN WITH SEVERAL HEALTHCARE PROVIDERS, INCLUDING SLEEP TECHNICIANS, AND HAVE FOUND NONE THAT SAY THE DEVICE WORKS AS DESCRIBED. I AM FILING THIS REPORT NOT ONLY ON MY OWN BEHALF, BUT ALSO MANY OTHERS THAT HAVE FOUND NO SUCCESS WITH THE DEVICE. I URGE THE FDA TO LOOK CLOSELY AT THIS PRODUCT, AND TAKE ACTION TO PREVENT INSPIRE FROM CONTINUING TO SELL AND IMPLANT THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357658 INSPIRE SLEEP APNEA STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC AIR310555C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other BI-PAP MACHINE.| ENTRESTO NEUPRO.| MAXIMUM ENDURANCE SEMENAX.| SPIROLACTONE.| TADALAFIL.| TRAZADONE.