BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MT DRIVE & STAR DRIVE AND ACCESSORIES

    MDR report key: 6418714 · Received March 20, 2017

    Report

    Report Number
    3002250546-2017-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 13, 2017
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DURING A DEEP BRAIN STIMULATION CASE AT (B)(6) MEMORIAL HOSPITAL WITH ATTENDING PHYSICIAN DR. (B)(6), THE CASE WAS ABORTED. THE PATIENT'S TONGUE WAS SWOLLEN AND OBSTRUCTED THE AIRWAY. THE PATIENT NEEDED TO BE BAGGED UNTIL STABLE. THE OPERATING ROOM STAFF NOTED THAT THE PATIENT MAY HAVE REACTED POORLY TO PROPOFOL. DR. (B)(6) INSTALLED THE NAVIGUS CAPS THEN CLOSED. THE SURGERY WILL BE RESCHEDULED IN THE COMING WEEKS WITH THE PATIENT AWAKE. ADDITIONAL DETAILS REGARDING THE CASE: (B)(6) DR. (B)(6) NEUROCOORDINATOR, (B)(4) FROM MEDTRONIC, (B)(4) FROM BRAINLAB TO ASSIST PLANNING, (B)(6) FROM NEURODYNAMICS FOR MER. BILATERAL STN TARGETS FOR PD USING STAR DRIVE MA WITH BRAINLAB FIDUCIARY SPHERES ATTACHED TO BACK OF CARRIAGE AND BRAINLAB REAL TIME TRACKING FIRST INCISION AT 10:25 3 TRACK MER WITH (B)(6) RUNNING LEADPOINT, 10:45 PERFORATOR FOR BURR HOLE, SHARP STYLET FIRST TRIAL. AT 11:03 ABORT PATIENT BREATHING PROBLEM. PATIENT RECOVERED ON THE OPERATING ROOM TABLE. DR.(B)(6) EMAILED NOTING THAT FHC PRODUCTS WERE NOT THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201425 MT DRIVE & STAR DRIVE AND ACCESSORIES NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC, INC, ST-DS-MA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening