BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿ PLANNING STATION

    MDR report key: 3190489 · Received June 26, 2013

    Report

    Report Number
    1723170-2013-00476
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN.SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE, RESEARCH PROGRAM MANAGER, PERFORMING PHANTOM WORK WITH A PLANNING STATION, IDENTIFIED UNEXPECTED BEHAVIOR IN THE GUIDANCE VIEW. THE PASSIVE BIOPSY NEEDLE WAS NEAR EXACT TARGET, -0.1MM OFF, HOWEVER, THE LINE SHOWING THE NEEDLE PLACEMENT WAS INCORRECT. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289849 STEALTHSTATION® S7¿ PLANNING STATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7 PLANNING STATION

    Patients

    Seq Age Sex Outcome Treatment
    1