BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 7945364 · Received October 8, 2018

    Report

    Report Number
    3007666314-2018-00043
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    September 21, 2017
    Report Date
    October 5, 2018
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    10855728005496
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PNEUMOTHORAX WAS CAUSED BY A SURGICAL TOOL CALLED A RIBBON RETRACTOR. THIS TOOL IS NOT MANUFACTURED BY INSPIRE MEDICAL SYSTEMS BUT SINCE IT CAUSED THE PNEUMOTHORAX WHILE BEING USED DURING AN INSPIRE IMPLANT PROCEDURE, SPECIFICALLY IN PREPARATION FOR PLACEMENT OF THE INSPIRE MODEL 4323 SENSING LEAD WE ARE FILING THIS MDR.

    Description of Event or Problem · 1

    DURING TUNNELLING, PRIOR TO PLACEMENT OF THE SENSOR LEAD, PHYSICIAN WAS USING A MALLEABLE RIBBON RETRACTOR WHICH IS NOT AN INSPIRE PRODUCT. THE RETRACTOR WAS PLACED INTO THE INTERCOSTAL SPACE BUT PLANED SLIGHTLY BELOW THE INTERNAL INTERCOSTAL FIBERS. A SLIGHT NOISE WAS NOTED AND SOME SMALL BUBBLES WERE OBSERVED. CORRECTIVE MEASURES WERE TAKEN TO MANAGE WHAT APPEARED TO BE A SMALL PNEUMOTHORAX. NO LUNG COLLAPSE OR VOLUME CHANGE WAS NOTED AND ONCE IT WAS DETERMINED THE SITUATION WAS STABLE THE SENSOR WAS PLACED AND THE CASE COMPLETED AS NORMAL. THE PATIENT WAS OBSERVED AND NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785278 INSPIRE SENSING LEAD MNQ INSPIRE MEDICAL SYSTEMS INC MODEL 4323 10855728005496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention