BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 4111571 · Received September 23, 2014

    Report

    Report Number
    1723170-2014-01014
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    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

    THE SOFTWARE LOGS WERE ANALYZED BY ENGINEERING. THE LOGS DID NOT CONTAIN ANY CONCLUSIVE EVIDENCE TO INDICATE WHY THE SOFTWARE EXITED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN.SOFTWARE INVESTIGATION NOT COMPLETED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED PULLING PATIENT EXAMS FROM A PLANNING STATION TO THE NAVIGATION SYSTEM, USING SYNERGY CRANIAL 2.2.6 AND WHEN THE TRANSFER COMPLETED, SYNERGY CRANIAL APPLICATION EXITED AND BECAME UNRESPONSIVE. IN TROUBLE-SHOOTING, THE MEDTRONIC REPRESENTATIVE RE-LAUNCHED THE SOFTWARE AND THE EXAMS TRANSFERRED PROPERLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592058 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1