BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2062250 · Received April 12, 2011

    Report

    Report Number
    1723170-2011-00777
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON SITE BY MEDTRONIC REPRESENTATIVES AND A MESSAGE WAS FOUND IN THE O-ARM SYSTEM LOGS STATING "MOVEMENT DETECTED" DURING SCAN. THE CAMERA ON THE STEALTHSTATION NAVIGATION SYSTEM WAS A LITTLE LOOSE AND IT WAS DETERMINED THAT THE CAMERA COULD HAVE MOVED SLIGHTLY DURING THE SCAN, CAUSING THE INACCURACY. A MEDTRONIC REPRESENTATIVE REPORTED THE CAMERA WAS LOOSE ON THE ARM. THE CAMERA WAS TIGHTENED, THE SYSTEM WAS TESTED AND FOUND TO BE ACCURATE. SYSTEM IS WORKING PROPERLY, NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON ALLEGED AN INACCURACY OF 3-4MM. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE SCANS LOOKED CORRECT ON THE MVS (MOBILE VIEWING SYSTEM) OF THE O-ARM AND, AGAIN, WHEN TRANSFERRED TO THE STEALTHSTATION. THE SURGEON TOOK A SCAN WITH A C-ARM WHICH SHOWED THE INSTRUMENT IN THE PEDICLE WHILE THE STEALTHSTATION SHOWED THE INSTRUMENT IN THE INNER BODY SPACE. THE SURGEON DISCONTINUED USE OF THE STEALTHSTATION TO COMPLETE THE PROCEDURE.

    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 67 YR