BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 6918980 · Received October 5, 2017

    Report

    Report Number
    3007666314-2017-00017
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 5, 2017
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    00855728005024
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED VOCAL CORD WEAKNESS AND NUMBNESS WHILE DEVICE WAS ACTIVATED, AND THESE ISSUES WOULD RESOLVE WHEN THE SYSTEM WAS DEACTIVATED. PATIENT DECIDED TO HAVE THE SYSTEM EXPLANTED, WHICH WAS ON (B)(6). THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695294 INSPIRE IMPLANTABLE PULSE GENERATOR MNQ INSPIRE MEDICAL SYSTEMS INC 3024 00855728005024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention