BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETNING INSERTION TUBE

    MDR report key: 5235468 · Received November 13, 2015

    Report

    Report Number
    3002250546-2015-00004
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    October 7, 2015
    Report Date
    November 11, 2015
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FHC PRODUCT REFERENCED HAS NO LOT NUMBER AVAILABLE. EVENT WAS DESCRIBED AS FOLLOWS: "EVENT DESCRIPTION: SURGEON ATTEMPTED 3 DIFFERENT PASSES WHILST DOING ON TABLE TESTING ON THE LEFT SIDE OF THE BRAIN. WHEN ATTEMPTING TO WAKE UP PATIENT FOR RIGHT BRAIN TESTING, THE PATIENT WAS SLEEPY AND GROGGY. IT WAS VERY DIFFICULT TO WAKE-UP PT. THE SURGEON COMPLETED A PAIN STIMULUS TEST, AND IT SHOWED TO BE NORMAL AT THE TIME. SURGEON IMPLANTED THE SECOND LEAD. ON COMPLETION OF THE CASE, THE SURGEON RE-DID THE PAIN STIMULUS RESPONSE AND IT SHOWED TO BE ABNORMAL. PATIENT THEN COMPLETED A POST OP CT SCAN, WHICH SHOWED THAT SHE HAD AN INTERNAL HEMORRHAGE. PT WAS TAKEN TO ICU AND IS STABLE. SURGEON BELIEVES THAT IT WAS DUE TO A HIGH BLOOD PRESSURE DURING THE MULTIPLE PASSES AND THAT IT IS NOT PRODUCT RELATED." THE SURGEON INDICATES FHC PRODUCT WAS NOT AT FAULT AND PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753878 MICROTARGETNING INSERTION TUBE HAW FHC, INC. 66-IT-05P

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization