BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 3640383 · Received February 21, 2014

    Report

    Report Number
    1723170-2014-00165
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW TIU (TOOL INTERFACE UNIT) WAS INSTALLED IN THE SYSTEM. THIS RESOLVED THE ISSUE AND SYSTEM IS NOW FULLY FUNCTIONAL. SUSPECT TIU HAS NOT BEEN SENT BACK TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. REPLACEMENT PART, OPT FIBER COMM IOR, SHIPPED TO SITE. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM EXPERIENCING INTERMITTENT COMMUNICATION WITH THE FOOT PEDAL. NO FOOT SWITCH IS ATTACHED. THE SITE IS NOT USING THE SOFTWARE KEY AND HAS TESTED IT WITH A SEPARATE MONITOR. ALL CONNECTIONS HAVE BEEN CHECKED TO VERIFY NO LOOSE CABLES. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110813 STEALTHSTATION IOR SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. IOR

    Patients

    Seq Age Sex Outcome Treatment
    1