BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2040356 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00661
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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

    THE SPRING ARM ASSEMBLY WAS RETURNED TO THE MFR FOR EVAL. THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. THE CABLE AND CONNECTORS WERE IN GOOD CONDITION WITH NO VISIBLE DAMAGE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE PART WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SIZE WAS EXPERIENCING BLACK STATUS. THE MEDTRONIC REP WALKED THROUGH TROUBLESHOOTING WITH THE SITE. THEY USED A CAMERA PHONE TO LOOK VIEW THE STEALTHSTATION TREON CAMERA AND IT SHOWED THAT THE LEDS WERE NOT FIRING. THEY THEN REBOOTED THE SYSTEM AND THIS RESOLVED THE ISSUE. THE SURGEON CONTINUED THE CASE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 69 YR