BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1878553 · Received October 1, 2010

    Report

    Report Number
    1723170-2010-00047
    Event Type
    Other
    Date Received
    October 1, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INTERFERENCE FROM UNK OBJECT IN PT, LATER IDENTIFIED BY RADIOLOGIST TO BE A BULLET, USE OF THE MEDTRONIC SYSTEM IN THIS SURGERY WAS ABORTED. THE TREON DEVICE WAS EVALUATED ON SITE AND PASSED HARDWARE SYSTEM CHECKOUTS WITHIN SPECIFICATIONS. THE SCANS WERE EVALUATED BY MEDTRONIC NAVIGATION'S ENGINEERING TEAM. SCANS WERE FOUND TO HAVE A HIGHER RANGE OF PIXEL DATA THAN A TYPICAL CT SCAN DUE TO THE PRESENCE OF A METAL BULLET. THE THRESHOLD SLIDER IN THE REGISTER TASK OF THE SOFTWARE FOR ADJUSTING THE DISPLAY RANGE FOR THE SYNTHETIC VIEWS IS HARD CODED AND WORKS FOR MOST SCANS, HOWEVER, IN A SCAN WITH METAL ARTIFACT, THE DATA RANGE BECOMES A HIGHER RANGE AND THE SCAN APPEARS WHITE-OUT RESULTING IN A POOR IMAGE QUALITY. THE BULLET WAS NOT DISCLOSED PRIOR TO SURGERY, THEREFORE, A SCAN NOT CONTAINING THE BULLET COULD NOT BE OBTAINED FOR THE CASE.

    Description of Event or Problem · 1

    SITE FILED MEDWATCH # (B)(4) ON (B)(6) 2010. MEDTRONIC REP REPORTED METAL INTERFERENCE CAUSING WHITE-OUT IMAGES DURING SURGERY. THERE WAS A BULLET IN THE PT WHILE ACQUIRING THE CT IMAGES. THE IMAGE DEFINITION WAS UNCLEAR. ARTIFACT WAS PREVALENT. THE USE OF THE MEDTRONIC SYSTEM WAS ABORTED. SURGERY CONTINUED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR