BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 6987935 · Received October 30, 2017

    Report

    Report Number
    3007666314-2017-00020
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    September 26, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION OF SENSOR LEAD FOR ONGOING PAIN. PATIENT HAD PERSISTENT PAIN IN THE INTERCOSTAL SPACE WHERE SENSOR LEAD WAS PLACED ABOUT 3 MONTHS AFTER THE SURGERY. DR. WAS MONITORING THIS PATIENT AS HE WAS NOT SURE IF IT WAS THE LEAD OR SOMETHING CERVICAL THAT WAS CAUSING THIS PAIN. WE HAD DONE A SYSTEM/COMPLIANCE CHECK AND PATIENT WAS DOING WELL IN THAT REGARD. LATER IT WAS DETERMINED THAT THE LEAD WAS PRESSING INTO A NERVE BRANCH. DR. DECIDED TO MOVE IT DOWN A LEVEL TO RELIEVE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768369 INSPIRE SENSING LEAD MNQ INSPIRE MEDICAL SYSTEMS INC 4323 00855728005000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention