BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3131957 · Received May 29, 2013

    Report

    Report Number
    1723170-2013-00385
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND TESTED THE NAVIGATION SYSTEM/INSTRUMENTS. HE WAS UNABLE TO REPLICATE ANY INACCURACY WHILE USING THE INSTRUMENTS. SOFTWARE INVESTIGATION PERFORMED WAS UNABLE TO DETERMINE ROOT CAUSE WITH AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS REPLACED IN THE SYSTEM. NO FURTHER SUBSEQUENT ISSUES HAVE OCCURRED SINCE COMPUTER REPLACEMENT. COMPUTER HAS NOT BEEN RETURNED FOR MANUFACTURER EVALUATION.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED AS SITE NOTED (B)(4) LAWS PROHIBITING DISCLOSURE. SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SURGEON ALLEGED AN INACCURACY WHEN CHECKING THE SCREW TRAJECTORY ON THE PATIENT. SCREW PLANS HAD BEEN CREATED. WHEN THE SURGEON COMPARED SCREW TRAJECTORY ON THE NAVIGATION SYSTEM TO THE 2D FLUORO IMAGE, HE DEEMED THE IMAGE ON THE STEALTHSTATION WAS INACCURATE. THE SURGEON OPTED TO DISCONTINUE USE OF THE NAVIGATION SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234415 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1