BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3782048 · Received April 30, 2014

    Report

    Report Number
    1723170-2014-00424
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    March 29, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO CANADIAN PATIENT PRIVACY REGULATIONS. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION INTO THE SOFTWARE ANOMALY FOUND THE ISSUE OCCURRED BECAUSE PROJECTION STATE (CAD INSTRUMENT) WAS MAINTAINED INCONSISTENTLY BETWEEN MULTIPLE OBJECTS. AS PART OF THE INSTRUMENT MANAGEMENT UPDATE IN THE SPINE SOFTWARE, THE PROJECTION STATE WAS CONSOLIDATED INTO A SINGLE OBJECT TO PREVENT INCONSISTENCIES FROM OCCURRING. THIS ISSUE WAS RESOLVED WITH THE RELEASE OF SYNERGY SPINE SOFTWARE VERSION 2.1.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE SURGEON ALLEGED THE SYSTEM WAS INACCURATE IN A SINGLE VIEW. THE SURGEON REGISTERED THE PATIENT SUCCESSFULLY, AND FOUND TRAJECTORY 1, 2, AND AP VIEWS WERE ALL ACCURATE AND THE TIP OF THE INSTRUMENT WAS BEING NAVIGATED WHERE IT SHOULD BE. THE LATERAL VIEW WAS FOUND TO BE INACCURATE AND SHOWED THE INSTRUMENT ABOUT 2 INCHES ABOVE THE ANATOMY WHEN IT WAS ACTUALLY TOUCHING THE ANATOMY. THE INACCURACY APPEARED TO BE INTERMITTENT AT FIRST AND THEN DURING TROUBLESHOOTING, THE ISSUE RECTIFIED ITSELF AND ACCURACY RETURNED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260571 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1