BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3033755 · Received April 3, 2013

    Report

    Report Number
    1723170-2013-00246
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A VIDEO OF THE REPORTED ISSUE WAS SENT IN FOR ENGINEERING ANALYSIS. THE PATIENT REFERENCE FRAME GEOMETRY WAS CHANGING FROM GREEN (ALL REFLECTIVE MARKER VISIBLE TO CAMERA) TO YELLOW (ONLY 3/4 OF THE MARKERS VISIBLE TO CAMERA) STATUS WHEN "JUMPING" OCCURS. THIS BEHAVIOR IS LIKELY DUE TO COMPENSATION FOR THE CAMERA NOT TRACKING ONE OF THE SPHERES AND THE SUBSEQUENT CHANGE IN GEOMETRY READ BY THE CAMERA/SOFTWARE. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A SPINAL SURGERY, WHILE NAVIGATING THE SMALL UNIVERSAL DRILL GUIDE (UDG), THE SOFTWARE DISPLAY OF THE INSTRUMENT ON THE MONITOR WAS UNSTEADY OR "JUMPING". THE CASE CONTINUED WITH NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136416 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 65