BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2872846 · Received December 13, 2012

    Report

    Report Number
    1723170-2012-00729
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED. PATIENT WEIGHT WAS NOT AVAILABLE FROM THE SITE. THE SITE HAD THEIR OWN BIOMED TECHNICIAN TEST THE SYSTEM. PER THE EQUIPMENT COORDINATOR AT THE SITE, THE PROBLEM WAS OPERATOR ERROR (INCORRECT SET-UP).

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM SITE AT TIME OF THIS REPORT. RETURN OF SUSPECT PART IS NOT EXPECTED. NO EVALUATION CAN BE CONDUCTED TO INVESTIGATE ROOT CAUSE OF ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THE FRAME AND THE PASSIVE PLANAR TRACKED INTERMITTENTLY. THE PATIENT WAS REGISTERED, THEN HALFWAY THROUGH THE PROCEDURE THE FRAME AND INSTRUMENTS FLASHED FROM RED TO YELLOW ON THE MONITOR SCREEN. IN TROUBLE-SHOOTING, CAMERA PLACEMENT WAS CHECKED, FINDING THE TRACKING DETAILS BOX WAS TOO CLOSE. NEXT, A MEDTRONIC REPRESENTATIVE GAVE INSTRUCTIONS TO MOVE THE CAMERA BETWEEN 4-6 FEET AWAY FROM THE FRAME. THE GEOMETRY ERROR OF THE CRANIAL FRAME WAS TOGGLING UP TO 0.5MM. MEDTRONIC TECHNICAL SERVICES REP INFORMED THEM THAT .5 MM IS THE MAX GEOMETRY ERROR WE ALLOW FOR TRACKING. THEN ASKED THE TECH TO COVER UP THE SPHERES ONE BY ONE ON THE FRAME TO SEE IF IT WOULD TRACK AND IT WENT TO YELLOW. BIO-MED WAS CALLED TO THE ROOM TO POWER DOWN THE SYSTEM; UNPLUG AND RE-PLUG IN THE CAMERA. AFTER CYCLING POWER THE SURGEON DECIDED TO DISCONTINUE NAVIGATION TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR