BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MEDICAL SYSTEMS DEVICE FOR OBSTRUCTIVE SLEEP APNEA

    MDR report key: 10091762 · Received May 26, 2020

    Report

    Report Number
    MW5094693
    Event Type
    Injury
    Date Received
    May 26, 2020
    Date of Event
    July 18, 2019
    Report Date
    May 23, 2020
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN INSPIRE MEDICAL SYSTEMS DEVICE TO PREVENT SLEEP APNEA WAS IMPLANTED IN MY CHEST. I IMMEDIATELY BECAME CRITICALLY ILL, SUFFERING A VARIETY OF PROBLEMS, INCLUDING ACUTE PULMONARY EDEMA. I WAS ON A RESPIRATOR FOR ABOUT SEVEN DAYS; WAS IN THE ICU FOR THREE WEEKS, AND I NEEDED MONTHS OF OCCUPATIONAL, SPEECH AND PHYSICAL THERAPY. I WAS OUT OF WORK FOR THE ENTIRE (B)(6) 2019. I SUFFERED AFTER-EFFECTS FOR ABOUT FIVE MONTHS. THE INSPIRE DEVICE WAS IMPLANTED BUT HAS NOT BEEN ACTIVATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554051 INSPIRE MEDICAL SYSTEMS DEVICE FOR OBSTRUCTIVE SLEEP APNEA STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R