BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MEDICAL SYSTEMS INC

    MDR report key: 6059123 · Received October 26, 2016

    Report

    Report Number
    3007666314-2016-00010
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    August 3, 2016
    Report Date
    October 26, 2016
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    UDI-DI
    00855728005017
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SURGEON NICKED THE PATIENT'S JUGULAR VEIN DURING THE IMPLANT SURGERY, SPECIFICALLY WHILE TUNNELLING IN PREPARATION FOR IMPLANT OF THE STIMULATION LEAD. THE SURGEON WAS ABEL TO STOP THE BLEEDING AND CONTINUED WITH THE IMPLANT OF THE SYSTEM. THE PATIENT IS DOING WELL AND IS RESPONDING NICELY TO THE THERAPY BUT THE PATIENTS SURGICAL PROCEDURE WAS PROLONGED BY 2.5 HOURS AS A RESULT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708392 INSPIRE MEDICAL SYSTEMS INC TUNNELLING TOOL MNQ INSPIRE MEDICAL SYSTEMS INC. MODEL 4063 00855728005017

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization