BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 12561430 · Received October 1, 2021

    Report

    Report Number
    12561430
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    June 9, 2021
    Report Date
    September 15, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PATIENT'S OVERNIGHT SLEEP STUDY FOR INSPIRE TITRATION, THE NEW INSPIRE DEVICE WAS USED FOR TITRATION. THE DEVICE KEPT REPORTING THAT THERE WAS ELECTRICAL INTERFERENCE. THE TECH CALLED THE INSPIRE TECH SUPPORT FOR GUIDANCE. HE WAS INSTRUCTED TO SWITCH TO THE OLD INSPIRE DEVICE. THE PATIENT COMPLAINED THROUGHOUT THE STUDY THAT IT WAS UNCOMFORTABLE AND DID NOT FEEL HOW IT USUALLY FELT. TECH STAYED IN CONTACT WITH INSPIRE TECH SUPPORT THROUGHOUT THE NIGHT. INSPIRE ADVISED HIM THAT THIS WAS NOT UNHEARD OF WHEN THE PATIENT WAS IN A NEW PLACE OVERNIGHT HAVING A STUDY PERFORMED. IN THE MORNING, INSPIRE TECH SUPPORT AND TECH CHECKED THE PREVIOUS STUDY SETTINGS AND NOTED DURING THIS TIME THAT THE DEVICE HAD SWITCHED FROM A +-+ CONFIGURATION TO A -+- CONFIGURATION ON ITS OWN AT SOME POINT IN THE NIGHT. THIS IS NOT A SETTING SWITCHED DURING A SLEEP STUDY TITRATION. TECH STATED HE DID NOT SWITCH THIS SETTING. REPRESENTATIVE FROM INSPIRE SPOKE WITH CLINIC STAFF THAT MORNING IN A THREE WAY PHONE CALL REGARDING THE INCIDENT. CLINIC STAFF FEELS THAT IT MAY BE THE INSPIRE PROGRAMMER TABLET AND IS REPORTING TO THEIR ENGINEERING TEAM. CLINIC STAFF STATED THAT AN FDA REPORT WILL BE MADE DUE TO THE MALFUNCTION OF A MEDICAL DEVICE. REPRESENTATIVE REQUESTED THE DEVICE FROM USE AND HOLD FURTHER INSPIRE TITRATIONS SO THE ENGINEERS CAN DETERMINE WHERE THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461591 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA