BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4243746 · Received November 11, 2014

    Report

    Report Number
    1723170-2014-01213
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2014, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE SURGEON WAS PERFORMING A ONE-LEVEL PROCEDURE, PLACED THE SCREW ON ONE SIDE AND THE INACCURACY WAS OBSERVED WHEN MOVING TO THE OTHER SIDE. THE SURGEON USED NON-NAVIGATED INSTRUMENTS TO CONTINUE AND COMPLETED THE PROCEDURE. THE MEDTRONIC REPRESENTATIVE WAS ON-SITE TROUBLE-SHOOTING, AND FOUND THE ORANGE NAVLOCK VERIFIED NORMALLY AND WAS ACCURATE WITH BOTH THE DRIVER AND THE TAP. THE NAVIGATION SYSTEM IS FUNCTIONING NORMALLY. NO FURTHER ISSUES HAVE BEEN REPORTED. (B)(4) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS ADDRESSED IN THE NEWEST VERSION OF SOFTWARE WHICH INCORPORATED A FIX FOR THIS ANOMALY. A MEDTRONIC REPRESENTATIVE UPGRADED THE SPINE SOFTWARE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON ALLEGED A LATERAL INACCURACY OF 5MM WHEN USING AN ORANGE NAVLOCK WITH 6.5 TAP AND A GRAY NAVLOCK WITH A SOLERA DRIVER. THE SURGEON RE-VERIFIED THE INSTRUMENTS SUCCESSFULLY, HOWEVER, CONTINUED TO NOTE THE INACCURACY. THE SURGEON DISCONTINUED THE USE OF THESE INSTRUMENTS AND USED NON-NAVIGATED INSTRUMENTS TO CONTINUE THE PROCEDURE. 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
    727432 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR