BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 12359700 · Received August 23, 2021

    Report

    Report Number
    MW5103456
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 19, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT TO SURGERY FOR IMPLANTATION OF INSPIRE DEVICE FOR OBSTRUCTIVE SLEEP APNEA. THE VENDOR WAS IN THE OPERATING ROOM SUITE AND PRIOR TO INSERTING THE BATTERY, IT WAS READING "LOW" SO THE PHYSICIAN AND VENDOR DECIDED TO USE THE BACK UP BATTERY. NO HARM TO THE PATIENT. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251956 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR