BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081212 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00873
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA, A REPLACEMENT CAMERA WAS SENT TO SITE. UPON EVAL OF RETURNED CAMERA, IT SHOWED PASSIVE TRACKING WAS REDUCED AT THE BACK OF THE VOLUME AFTER WARM UP. THE POSITION SENSOR UNIT (PSU) PASSED THE AAK TEST. THE TEST SOFTWARE WAS NOT ABLE TO MAKE AN ADJUSTMENT FOR LINE SEPARATION.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SYSTEM WOULD FLICKER BACK AND FORTH BETWEEN GREEN AND RED STATUS ON THE TREON NAVIGATION SYSTEM. THIS HAPPENED ONCE ON THE FRAME AND SEVERAL TIMES ON THE PASSIVE INSTRUMENTS. THE SURGEON SWITCHED TO ACTIVE INSTRUMENTS AND IT TRACKED FINE. NO IMPACT ON PT OUTCOME WAS REPORTED.

    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 UNK