BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 11920094 · Received June 2, 2021

    Report

    Report Number
    11920094
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    April 8, 2021
    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

    REF (B)(4) IMPEDANCES WERE RUN ON DEVICE. THE SURGEON AND REP DETERMINED THERE TO BE ABNORMALITIES, SO ANOTHER INSPIRE GENERATOR WAS OPENED TO COMPLETE THE PROCEDURE. REF: (B)(4)- THE WAVEFORM LOOKED SMALLER THAN EXPECTED. SURGEON AND REP DETERMINED THAT EXPLANTING AND INSERTING A NEW DEVICE WAS THE BEST COURSE OF ACTION. BOTH FAILED PRODUCTS HAD PATIENT CONTACT BUT NO PATIENT HARM. MANUFACTURER RESPONSE FOR INSPIRE GENERATOR AND SENSORY LEAD, (BRAND NOT PROVIDED) (PER SITE REPORTER): THE FAILED PRODUCTS WERE PICKED UP BY FIELD REP AND REPLACEMENTS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816453 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. 3028 AND 4340 S11288 AND AIR315672C

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA