BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION STEALTH STATION S7 SYSTEM

    MDR report key: 8143663 · Received December 7, 2018

    Report

    Report Number
    1723170-2018-06137
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 26, 2018
    Report Date
    June 4, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE SCU WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THERE WAS A FAULT SYNCHRONIZATION BETWEEN THE CAMERA AND THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU). ONCE THE SCU WAS REPLACED, THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE SCU WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: INITIAL REPORTER UPDATED TO (B)(6) (SURGEON). 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 BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THERE WAS A FAILED SYNCHRONIZATION BETWEEN THE CAMERA/POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) AND THE COMPUTER. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980689 NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1