BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 11920015 · Received June 2, 2021

    Report

    Report Number
    11920015
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    November 10, 2020
    Report Date
    May 7, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED AT THE END OF THE CASE. WHEN THE EFFICACY WAS TESTED, THE DEVICE WOULDN'T ACTIVATE. MULTIPLE TROUBLESHOOTING WAS TRIED, THEN DEVICE WAS EXPLANTED AND REPLACED WITH NEW ONE. THE PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR IMPLANTABLE GENERATOR INSPIRE, (BRAND NOT PROVIDED) (PER SITE REPORTER): THE PRODUCT PICKED UP BY FIELD REP AND A REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817013 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. 3028 AIR312050

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA