BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2062203 · Received April 12, 2011

    Report

    Report Number
    1723170-2011-00774
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE CAMERA WAS REPLACED AND PASSED ALL TESTING. PASSIVE TRACKING RANGE WAS FOUND TO BE REDUCED AT POWER UP. HOWEVER, AFTER A SHORT WARM UP OF TWENTY MINUTES, PASSIVE TRACKING RETURNED TO NORMAL AND REMAINED FOR THE DURATION OF THE FUNCTIONAL TEST. THIS IS CONSIDERED NORMAL BEHAVIOR AS THE CAMERA SHOULD BE ALLOWED TO WARM UP TO OPERATING TEMPERATURE BEFORE USE. ISSUE OCCURRED BECAUSE USER DID NOT ALLOW SYSTEM TO WARM UP.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE CAMERA RECOGNITION OF ACTIVE AND PASSIVE INSTRUMENTS IS PERIODICALLY NOT WORKING PROPERLY. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TRIA NAVIGATION SYSTEM STEREOTAXIC SURGICAL SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. TRIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE