BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6323962 · Received February 10, 2017

    Report

    Report Number
    1723170-2017-00506
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    October 13, 2016
    Report Date
    February 10, 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

    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 01/17/2017, 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. INVESTIGATION OF RETURNED SUSPECT DEVICE FOUND THAT THE PSU POWERED UP WITH ALL THE LEDS LIT. IN THIS CONDITION, THE PSU WAS UNABLE TO INITIALIZE OR COMMUNICATE WITH THE SCU. A CHECK OF THE EVENT LOG INDICATED THE FIRMWARE WAS MISSING OR CORRUPTED. THE FIRMWARE WAS ABLE TO BE UPDATED TO REVISION 14. THE PSU WAS THEN ABLE TO COMMUNICATE WITH THE SCU AND TRACK INSTRUMENTS. THE PSU PASSED AN AAK TEST AT .23 MM WITH A PASSING THRESHOLD OF .35 MM BUT HAD GREAT DIFFICULTY TRACKING THROUGH THE BACK END OF THE VOLUME. DUE TO THE AGE AND CONDITION OF THE PSU, IT WILL NOT BE REPAIRED AND RETURNED TO SERVICE INVENTORY. A REPLACEMENT CAMERA WAS SHIPPED TO THE SITE. THE ISSUE WAS RESOLVED WITH THE REPLACEMENT. A FULL SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM'S CAMERA WAS CYCLING WITHIN THE CRANIAL APPLICATION. IT WAS ALSO NOTICED THE SYSTEM DID NOT WORK. SHE ATTEMPTED TO RUN THE CAMERA FIRMWARE (REV 14) BUT IT SHOWED THAT THE CAMERA WAS NOT CONNECTED. THE MDT REP TRIED A DIFFERENT SYSTEM'S CAMERA AND THE SYSTEM WAS FULLY FUNCTIONAL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105038 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1