BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6908930 · Received October 2, 2017

    Report

    Report Number
    1723170-2017-03989
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994653482
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE LOGS FOR THE NAVIGATION SYSTEM WERE SENT IN AND REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE LOGS PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY. FOLLOWING LOG ANALYSIS, THE REPRESENTATIVE RETURNED TO THE SITE AND REPLACED THE COMPUTER FOR THE NAVIGATION SYSTEM TO RESOLVE THE REPORTED ISSUE. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE COMPUTER FOR THE NAVIGATION SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPUTER WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE WHEN ENTERING THE DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) QUERY RETRIEVE (Q/R) PORTION OF THE SOFTWARE. THE NAVIGATION SYSTEM WAS REPORTED TO BE UNRESPONSIVE TO THE CTRL+ALT+DELETE PROMPT FROM THE USER. A HARD RESTART WITH THE POWER BUTTON WAS PERFORMED, AND ON THE THIRD ATTEMPT THE SYSTEM POWERED ON. THE COMPUTER OF THE NAVIGATION SYSTEM WAS REPORTED TO HAVE POWERED ON AND THAT THE MOUSE AND TOUCH SCREEN BECAME UNRESPONSIVE WHEN ENTERING DICOM QR A SECOND TIME. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688233 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1