BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2121748 · Received May 20, 2011

    Report

    Report Number
    1723170-2011-00982
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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 SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES. SUBSEQUENT USE OF THE SYSTEM SHOWED NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE IN SURGERY TO PLACE GUIDE WIRES BY THE DRILL GUIDE WITH THE TREON AND O-ARM, THE GUIDE WIRES ON THE LEFT SIDE SEEMED HIGHER THAN THE SURGEON WAS USED TO. HE SAID THAT WHEN DOING THE PT'S RIGHT SIDE, EVERYTHING LOOKED GREAT. THEY TOOK A LATERAL X-RAY WITH THE O-ARM AND THE PLACEMENT WAS GOOD. HOWEVER, ON THE LEFT SIDE, THE GUIDE WIRES LOOKED TOO HIGH. THE SURGEON DID ANOTHER SPIN AND TRIED TO REPLACE THE GUIDE WIRES THREE TIMES. THE SURGEON FELT THAT THE NAVIGATION WAS NOT ACCURATE. HE REPORTED THAT THE REFERENCE FRAME HAD NOT MOVED. THE SURGERY WAS COMPLETED USING THE SYSTEM WITH NO IMPACT TO THE PT.

    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 23 YR O-ARM 1000 IMAGING SYSTEM