BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3411705 · Received October 15, 2013

    Report

    Report Number
    1723170-2013-00832
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 23, 2013
    Report Date
    September 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    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

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE AND IS RELATED TO LEAVING THE SYSTEM ON OVERNIGHT, IDLE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. AFTER THE RE-START, SEVERAL SUCCESSFUL CASES WERE COMPLETED AND THERE WERE NO FURTHER ISSUES. NO PARTS/FILES RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM THAT WAS UNRESPONSIVE AND REQUIRED A RE-BOOT TO RESTORE TO NORMAL FUNCTION. THIS OCCURRED AT THE START OF THE DAY, PRIOR TO USE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527122 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1