BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7297590 · Received February 26, 2018

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    Report

    Report Number
    1723170-2018-00861
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 30, 2018
    Report Date
    May 16, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    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

    DEVICE EVALUATION: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE ISSUE COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. PART NOT RETURNED FOR ANALYSIS

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL RESECTION PROCEDURE, THE DYNAMIC REFERENCE FRAME (DRF) PATIENT TRACKER WAS FLICKERING IN AND OUT OF TRACKING STATUS. IT WAS REPORTED THAT THE DRF WAS PLUGGED INTO DIFFERENT PORTS ON THE AXIEM BOX, BUT THE ISSUE OCCURRED EVEN WITH THE EMITTER TRACKING VIEW ADJUSTED. THERE WERE NO ISSUES WITH FLICKERING TRACKING WITH OTHER INSTRUMENTS. TWO DIFFERENT DRF PATIENT TRACKERS WERE TESTED AND BOTH WERE FLICKERING. IT WAS POSSIBLE TO CONTINUE WITH NAVIGATION INSPITE OF THIS. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 15 MINUTES DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139358 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR