BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6330615 · Received February 14, 2017

    Report

    Report Number
    1723170-2017-00657
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    May 5, 2016
    Report Date
    February 14, 2017
    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

    THE INITIAL REPORT OCCURRED ON (B)(6) 2016 AND WAS FOUND TO BE A NON-REPORTABLE MALFUNCTION BASED ON THE INFORMATION AVAILABLE AT THE TIME THE EVENT OCCURRED. ON (B)(6) 2017, A RETROSPECTIVE REVIEW RELATED TO A CAPA WAS COMPLETED FOR ALL EVENTS WHERE THE REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES; THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. A MEDTRONIC REPRESENTATIVE TESTED THE EQUIPMENT, LEADING TO THE REPLACEMENT OF THE SGN MONITOR. AFTER PART REPLACEMENT, THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE(LCD MONITOR MALFUNCTION). THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING CATHETER-BASED PROCEDURE, THE SURGEON MONITOR FLICKERED AND THEN SHUT OFF. THE SURGEON CONTINUED JUST USING THE STAFF MONITOR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111661 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR