BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3770603 · Received April 24, 2014

    Report

    Report Number
    1723170-2014-00407
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    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

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. ANALYSIS OF THE SYSTEM LOGS CONFIRMED THE REPORTED EVENT. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    PATIENT AGE NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, AND WAS UNABLE TO REPLICATE THE ISSUE. SITE RELOADED THE SPINE2.0.1 SOFTWARE AND TOOLS IN ADDITION TO REMOVING AND READDING THE SURGEON PROFILE. THE MEDTRONIC REPRESENTATIVE ALSO INSTRUCTED SITE STAFF NOT OPEN O-ARM ON THE LAST SPIN UNTIL THE IMAGE HAS TRANSFERRED TO NAVIGATION SYSTEM.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE SOFTWARE BECAME UNRESPONSIVE. THE SITE TOOK FIVE SPINS AND WHILE NAVIGATING ON THE FOURTH SPIN, THE SYSTEM STOPPED NAVIGATING. THE SITE DID A SOFT REBOOT TO THE SYSTEM AND UPON REBOOT ENTERED BACK INTO THE SURGEON'S PROFILE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM AFTER A 10 MINUTE DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249685 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 O-ARM 1000 IMAGING SYSTEM