BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2043181 · Received February 24, 2011

    Report

    Report Number
    1723170-2011-00156
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS NOT AVAILABLE AT THE TIME OF THIS RETROSPECTIVE REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THE CAMERA WAS REPLACED ON THE SYSTEM AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINE SURGERY THE SITE WAS UNABLE TO TRACK THE O-ARM AND PATIENT REFERENCE FRAME OF THE NAVIGATION SYSTEM AT SAME TIME AND BOTH WOULD TRACK INTERMITTENTLY. HE SAID HE COULD TRACK THE DEVICES INDIVIDUALLY WITHOUT ISSUE BUT COULD NOT GET BOTH TO TRACK PROPERLY WHEN TOGETHER. HE SAID LIGHTING AND SETUP WERE NOT ISSUES, AND HE ADJUSTED THE CAMERA SETUP BUT WAS STILL UNABLE TO CORRECT THE ISSUE. HE SWAPPED THE FRAME SEVERAL TIMES AS WELL TO CONFIRM THAT THERE WERE NO GEOMETRY ERROR ISSUES. HE ALSO ENSURED THE CAMERA LENSES WERE CLEAN. THE SURGEON DISCONTINUED USE OF THE SYSTEM, STOPPED THE SURGERY, AND RESCHEDULED THE SURGERY FOR ANOTHER DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention