BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2917013 · Received January 15, 2013

    Report

    Report Number
    1723170-2013-00026
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 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

    UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY. AS PER MEDTRONIC INSTRUCTIONS, THE RELIASPHERES ARE NOT APPROVED OR VALIDATED BY MEDTRONIC. THE USE OF UNTESTED/UNVALIDATED SPHERES MAY IMPACT NAVIGATION PERFORMANCE INCLUDING SYSTEM ACCURACY. PER THE CASE DESCRIPTION, THE ACCURACY WAS NOT SEEN AFTER THE SITE SWITCHED TO MEDTRONIC APPROVED, IZI SPHERES.

    Additional Manufacturer Narrative · 1

    SYSTEM LOG FILES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR SOFTWARE EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A 1-2MM INACCURACY DURING A SPINE FUSION PROCEDURE WHILE USING THE RIGHT AND LEFT TACTILE PROBE AND THORACIC PROBE. THE SITE WAS USING RELIASPHERES. THE MEDTRONIC REPRESENTATIVE CHANGED THEM TO IZI SPHERES AND THERE WERE NO FURTHER ISSUES WITH ACCURACY. THE SURGEON ALSO MADE A CHANGE TO NAVLOCK AND CONFIRMED THEY WERE ACCURATE. THE PROCEDURE WAS COMPLETED WITH THE USE OF STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22650 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR