BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2201325 · Received August 3, 2011

    Report

    Report Number
    1723170-2011-01262
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED, A REPLACEMENT PSU AND SPRING ARM WERE SHIPPED TO SITE ON (B)(4) 2011. INVESTIGATION FINDS THAT THE SUSPECT PSU PASSED SUBSEQUENT FUNCTIONAL AND AAK TESTS AND IS NOW FULLY FUNCTIONAL. ISSUE RESOLVED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, (B)(6), REPORTED THAT WHILE IN A CRANIAL SURGERY, THE STEALTHSTATION TREON GUIDANCE SYSTEM CAMERA DISPLAYED A DECREASED TRACKING VOLUME AND THEY WERE UNABLE TO TRACK THE FRAME AND THE PROBE AT THE SAME TIME. THE NURSE STATED THEY REGISTERED THE PT, BUT THEY WERE UNABLE TO VERIFY ACCURACY WITH THE SYSTEM BECAUSE THE PROBE WAS FLICKERING BETWEEN YELLOW AND GREEN STATUS. A MEDTRONIC REPRESENTATIVE WALKED THE SITE THROUGH TROUBLESHOOTING, HOWEVER, THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON PT OUTCOME.

    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 69 YR