BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2092158 · Received April 27, 2011

    Report

    Report Number
    1723170-2011-00917
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT NOT AVAILABLE FROM THE SITE. THE TRIA NAVIGATION SYSTEM HAD A DAMAGED ETHERNET CONNECTOR THAT CAUSED THE INABILITY TO OBTAIN A 3D SPIN FOR NAVIGATION. A REPLACEMENT CONNECTOR WAS SENT TO THE SITE. THE SYSTEM HAS BEEN USED SUCCESSFULLY SINCE THIS ISSUE WITHOUT ANY PROBLEMS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE IN A SPINE SURGERY, THE SITE WAS HAVING DIFFICULTY WITH PERFORMING A 3D SPIN. IT WAS REPORTED TO THE MEDTRONIC REP THAT SOMEONE HAD "TRIPPED OVER THE NETWORK CABLE" WHICH UNPLUGGED IT. THEY WERE THEN ABLE TO RECONNECT THE CABLE AND ATTEMPTED TO PERFORM A 3D SPIN, WHICH FAILED. THEY UNPLUGGED THE CABLE AND WERE ABLE TO PERFORM A 3D SPIN. ON THE THIRD ATTEMPT, WITH CABLE CONNECTED, THEY RECEIVED A "MOTION DETECTED" MESSAGE, BUT NO 3D SPIN WAS PERFORMED. THE SITE REP REPORTED HE WAS CERTAIN THE O-ARM WAS "STRAIGHT UP AND DOWN." THE SURGEON OPTED TO COMPLETE THE SURGERY WITHOUT THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR