BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2043276 · Received February 25, 2011

    Report

    Report Number
    1723170-2011-00163
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL REPORTED THE PT WEIGHT WAS UNAVAILABLE. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. SYNERGY SPINE SOFTWARE BELIEVED TO BE THE PROBLEM AS 98% OF THE HARD DRIVE IS FULL. SYSTEM INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THE SITE TECHNICAL SUPPORT ASSISTANT, CALLED IN DURING A SPINE PROCEDURE TO REPORT THAT ONLY PART OF THE O-ARM EXAM WAS TRANSFERRED TO THE STEALTH NAVIGATION SYSTEM. PER THE SITE REPRESENTATIVE, THE COMPLETE EXAM WAS DISPLAYED ON THE MOBILE VIEWING SYSTEM. AFTER TROUBLE-SHOOTING WITH MEDTRONIC TECHNICAL SERVICES, THE ISSUE WAS NOT RESOLVED. SURGEON DETERMINED THAT THE EXAM WAS MISSING PART OF THE IMAGE IN THE SAGITTAL PLANE. THE SURGEON OPTED TO PROCEED WITH THE CASE WITHOUT THE STEALTHSTATION TREON SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR