BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6182714 · Received December 16, 2016

    Report

    Report Number
    1723170-2016-05839
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 21, 2016
    Report Date
    March 20, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 INSPECTED THE NAVIGATION SYSTEM ON-SITE. WHEN THIS ISSUE WAS HAPPENING FREQUENTLY, THE REPRESENTATIVE UNINSTALLED THE APPLICATION INCLUDING SHARED RESOURCES COMPLETELY. WHEN RELOADING THE SOFTWARE, THE REPRESENTATIVE WAS GETTING AN ERROR MESSAGE STATING THAT THE SYSTEM WAS UNABLE TO INSTALL. IT KEPT FAILING TO INSTALL EACH TIME; THAT IS WHEN THE COMPUTER WAS REPLACED. THE ISSUE WAS RESOLVED WITH COMPUTER REPLACEMENT. THE MALFUNCTIONING COMPUTER HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A FULL NAVIGATION SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE NAVIGATION SYSTEM WAS BECOMING UNRESPONSIVE INTERMITTENTLY. THE USER ATTEMPTED TO UNINSTALL AND THEN REINSTALL THE SOFTWARE, BUT THE SOFTWARE WAS UNABLE TO COMPLETE THE INSTALL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833248 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1