BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 8211104 · Received January 2, 2019

    Report

    Report Number
    1723170-2019-00046
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    May 2, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. TESTING REVEALED THAT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS NOT WORKING. THIS WAS RESOLVED BY REPLACING THE SCU. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SCU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE SCU WOULD NOT POWER UP ON THE TEST BENCH. A CHECK OF THE FUSES FOUND THAT ONE HAD BLOWN. AFTER REPLACING THE BLOWN FUSE, THE SCU POWERED UP AND HAD NORMAL FUNCTION. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT THE CAMERA WAS NOT WORKING. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3402 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1