BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 6988423 · Received October 30, 2017

    Report

    Report Number
    3007666314-2017-00022
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 17, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF IMPLANT WHILE ANCHORING THE SENSING LEAD, THE SURGEON NOTICED SOME AIR BUBBLES FROM THE LEAD TRACT. SHE WAS CONCERNED WITH POSSIBLE PNEUMOTHORAX SO SHE INJECTED SOME SALINE AND ASKED ANESTHESIA FOR SOME MANUAL BREATHS. DID NOT NOTICE ANYTHING MORE SO SHE CONTINUED WITH PROCEDURE. SHORTLY AFTER, WHEN ANCHORING THE SECOND ANCHOR MORE AIR BUBBLES WERE NOTICED. SHE CALLED FOR XRAY POST IMPLANT BEFORE WAKING THE PATIENT. XRAY READ BY RADIOLOGIST AND A PNEUMOTHORAX WAS DETECTED. THE PATIENT RETURNED TO HOSPITAL AND WAS ADMITTED AND A CHEST TUBE WAS INSERTED TO TREAT THE PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768680 INSPIRE SENSING LEAD MNQ INSPIRE MEDICAL SYSTEMS INC 4323 00855728005000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention