BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 12195909 · Received July 20, 2021

    Report

    Report Number
    12195909
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 8, 2021
    Report Date
    July 14, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IMPLANTED PULSE GENERATOR AND LEAD STIMULATOR WERE NOT PROVIDING STIMULATION TO THE PATIENT'S TONGUE FOR THE TREATMENT OF SLEEP APNEA. PATIENT HAD A PROCEDURE TO REMOVE INTERNAL PULSE GENERATOR AND LEAD STIMULATOR AND REPLACE WITH A NEW GENERATOR AND LEAD. THE EXPLANTED DEVICE WAS GIVEN TO THE MANUFACTURER REPRESENTATIVE FOLLOWING THE PROCEDURE. IT WILL BE RETURNED FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA, INSPIRE (PER SITE REPORTER). A MANUFACTURER REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE TO ASSIST IN TESTING THE REPLACEMENT DEVICE. THEY RETRIEVED THE EXPLANTED DEVICE 2 DAYS LATER AND WILL RETURN IT TO CORPORATE QUALITY FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096307 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. 900-007-014

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA