BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4241214 · Received November 10, 2014

    Report

    Report Number
    1723170-2014-01205
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPRESENTATIVE REPORTING, NOTED THAT WHEN TROUBLE-SHOOTING DURING THE PROCEDURE, A MEDTRONIC TECHNICAL SUPPORT REPRESENTATIVE EXPLAINED, AFTER THE TRACER REGISTRATION PASSED, THAT THE ALGORITHMS FOCUS ON THE POINT OF THE NOSE AND IF THERE ARE ANY OBSTRUCTIONS, THE MACHINE WILL MIS-READ. ON 10/22/2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. SOFTWARE INVESTIGATION COMPLETED; FINDINGS ARE THAT THE FIDUCIALS WERE PLACED IN A SYMMETRICAL PATTERN ALONG THE TOP OF THE PATIENT'S HEAD. SOFTWARE IS FUNCTIONING AS DESIGNED; DETERMINED TO BE THE RESULT OF A USE ERROR. ON 11/03/2014 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT THE SITE IS AWARE THE FIDUCIAL PLACEMENT CAUSED THE REPORTED EVENT AND THEY HAVE BEEN TRAINED HOW TO PROPERLY PLACE FIDUCIALS. AFTER REVIEWING THE SCAN WITH TWO OF THE VIDEOGRAPHERS THAT RUN THE NAVIGATION SYSTEM, THEY AGREED THAT THE FIDUCIAL PLACEMENT WAS NOT VERY GOOD. THE 3D MODEL WAS PRISTINE, THE PATIENT JUST HAD MULTIPLE TUBES/SHUNTS COMING OUT OF THE HEAD THAT COULD HAVE INTERFERED WITH THE REGISTRATION AND HINDER THEIR NORMAL FIDUCIAL PLACEMENT. THE STAFF THAT RUNS THE NAVIGATION SYSTEM THERE IS VERY GOOD AND RECOGNIZED WHAT WENT WRONG WITH THE FIDUCIALS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, EQUIPMENT TECHNICIAN, ALLEGED AN INACCURACY OCCURRING WHILE IN A CRANIAL VENTRICULOSTOMY REPLACEMENT PROCEDURE. IT WAS REPORTED THAT 12 FIDUCIALS WERE PLACED ON THE PATIENT WHO WAS PERSPIRING. AFTER RECEIVING THE SCANS FROM COMPUTED TOMOGRAPHY (CT), IT WAS NOTED THAT TWO OF THE FIDUCIALS HAD FALLEN OFF. THE SURGEON WAS INFORMED OF THE TWO FIDUCIALS THAT WERE NOT PRESENT IN THE SCAN. USING TOUCH-N-GO REGISTRATION, THE SURGEON REGISTERED 7 POINTS AND CHECKED ACCURACY, NOTING THAT THE STYLUS WAS MARKING THE OPPOSITE SIDE OF THE SCREEN FROM WHERE THE TRACER STYLUS WAS BEING POINTED. IN TROUBLE-SHOOTING, THE PATIENT WAS RE-REGISTERED USING TOUCH-N-GO, MAKING POINTS OF CONTACT ON OPPOSITE MARKERS, THIS DID NOT RESOLVE THE ISSUE. THE PATIENT WAS THEN RE-REGISTERED USING TRACER REGISTRATION, FACIAL LANDMARKS WERE CHECKED FOR ACCURACY AND CONFIRMED IMPROVEMENT. ONCE THE PROCEDURE WAS UNDERWAY, THERE WERE ISSUES WITH AXIEM SEEING THE VENTRICULOPERITONEAL (VP) SHUNT STYLUS. THE SITE REPRESENTATIVE STATED THIS COULD EASILY HAVE BEEN AN ISSUE WITH THE AXIEM PLACEMENT AS IT WAS DETERMINED THAT WHEN CHECKING, THE PATIENT'S HEAD WAS FARTHER AWAY FROM IT, AFTER SETTING IT IN PLACE. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM AND FREE-HANDED THE SHUNT. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723810 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR