BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1915259 · Received November 2, 2010

    Report

    Report Number
    1723170-2010-00072
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP PERFORMED A SYSTEM EVAL ON THE STEALTHSTATION AND DETERMINED THE HARD DRIVE WAS 100% FULL AND IMAGES WERE NOT ABLE TO TRANSFER TO THE STEALTHSTATION. THE SITE WAS INFORMED OF THE FULL HARD DRIVE AND NOTIFIED TO DELETE EXAMS. SITE CONFIRMED THEY DELETED EXAMS AND THAT THE SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT DURING A THORACIC SPINE CASE, SITE TRANSFERRED IMAGES TO O-ARM MVS WITHOUT ISSUE, HOWEVER, WHEN TRANSFERRED TO THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM, IMAGES WERE SMALL AND COULD NOT ZOOM OR MAGNIFY. THE O-ARM MVS DISPLAYED 'WAITING TO TRANSFER EXAMS' BUT THE EXAMS DID NOT TRANSFER OVER TO THE TREON. PT WAS EXPOSED TO RADIATION FROM FIVE UN-UTILIZED SPINS. THE SITE ABORTED USE OF THE STEALTHSTATION TREON AND CONTINUE WITH USE OF A C-ARM. NO FURTHER IMPACT TO PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR MEDTRONIC STEALTHSTATION