BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3002609 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00181
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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

    BOTH CAMERAS (PSU OR POSITION SENSOR UNIT) THAT HAD BEEN SENT TO THE SITE WERE EVALUATED IN HOUSE BY THE MANUFACTURER AND FOUND TO BE FULLY FUNCTIONAL, ALBEIT THE SECOND CAMERA TOOK SOME TIME TO WARM UP (20-30 MINUTES) BEFORE THE COMPLETE TRACKING VOLUME WAS APPARENT. THIS IS CONSIDERED NORMAL FUNCTION. THE ORIGINAL SUSPECT PSU WAS FOUND TO HAVE NORMAL TRACKING THROUGHOUT THE VOLUME DURING FUNCTIONAL TESTING. THE PSU PASSED THE AAK TEST AT .43MM WITH MINIMAL LINE SEPARATION OF .20MM INDICATING THAT THE PSU ACCURACY AND TRACKING ARE NORMAL. A SECOND SET OF TESTS CONFIRMED THE INITIAL RESULTS. NO PROBLEM FOUND. UNABLE TO REPRODUCE ALLEGED INACCURACY.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACED STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM CAMERA TWICE, FIRST SHIPPED TO SITE (B)(4) 2013, A SECOND SHIPPED (B)(4) 2013. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION. IN THE INITIAL PLANNED MAINTENANCE VISIT, THE MEDTRONIC REPRESENTATIVE RAN A NAVIGATION SYSTEM CHECK-OUT AND HARDWARE SYSTEM CHECK, ALL AREAS PASSED. THE TREON CAMERA WAS REPLACED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE IDENTIFIED, DURING PLANNED MAINTENANCE, A 3-5MM INACCURACY THAT OCCURRED WHEN REGISTERING WITH TRACER AND POINT MERGE USING MULTIPLE FRAMES AND PROBES ON A RESIN TEST HEAD. THE MEDTRONIC REPRESENTATIVE ENSURED THE CAMERA HAD BEEN ON FOR GREATER THE 20 MINUTES, WAS ABLE TO TRACK 4'-7' AWAY AND CONFIRMED THE SPHERE OF ACCURACY WAS 1.2MM. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104607 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1