BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 6988197 · Received October 30, 2017

    Report

    Report Number
    3007666314-2017-00021
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 30, 2017
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    UDI-DI
    00855728005000
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN FOR HIS ACTIVATION APPOINTMENT YESTERDAY AFTERNOON AND INFORMED US THAT HE HAD A SLIGHT INFECTION IN HIS BREATHING SENSOR INCISION. PATIENT SAID HE SAW THE NURSE PRACTITIONER FOR HIS POST-OP VISIT WHO PUT HIM ON ANTIBIOTICS FOR SEVERAL WEEKS WHICH RESOLVED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768818 INSPIRE SESNING LEAD MNQ INSPIRE MEDICAL SYSTEMS INC. 4323 00855728005000

    Patients

    Seq Age Sex Outcome Treatment
    1