BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTH STATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1878551 · Received October 1, 2010

    Report

    Report Number
    1723170-2010-00052
    Event Type
    Other
    Date Received
    October 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 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

    PT INFORMATION UNAVAILABLE AT THE TIME OF REPORT BUT HAS BEEN REQUESTED. DUE TO METAL INTERFERENCE IN PT, IDENTIFIED AS A STAPLE, USE OF THE MEDTRONIC SYSTEM IN THIS SURGERY WAS ABORTED. SYSTEM CHECK-OUT HAS BEEN REQUESTED. RESULTS WILL BE REPORTED UPON RECEIPT. 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 STAPLE. 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.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED METAL INTERFERENCE CAUSING WHITE-OUT IMAGES DURING SURGERY. MEDTRONIC REP COULD SEE CAGE AND STAPLES IN THE PT DURING THE EXAM. THE USE OF THE MEDTRONIC SYSTEM WAS ABORTED. SURGERY CONTINUED. NO IMPACT ON PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK