BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON PLUS

    MDR report key: 823849 · Received February 27, 2007

    Report

    Report Number
    1723170-2007-00001
    Event Type
    Other
    Date Received
    February 27, 2007
    Date of Event
    February 7, 2007
    Report Date
    February 15, 2007
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON DID NOT FOLLOW RECOMMENDED INSTRUCTIONS TO ABORT USE OF APPLICATION IF NAVIGATION SEEMS INACCURATE NOR DID THE SURGEON CONTACT MNAV FOR ASSISTANCE. PT EXPERIENCED PRESSURE BEHIND EYE, WHICH REQUIRED A SECONDARY PROCEDURE (NOT NAVIGATED). PT'S PROGNOSIS DOES NOT INDICATE ANY PERMANENT DAMAGE.

    Description of Event or Problem · 1

    ALLEGED PT INJURY DURING A NAVIGATED FESS CASE WITH DR. THE SITE REPORTED TO HAVE SCANNED THE PT USING A XORAN SCANNER AND USED TRACER AS THEIR METHOD FOR REGISTRATION. THE SITE ALSO REPORTED THAT THE SYSTEM APPEARED ACCURATE ON THE ANTERIOR SURFACE OF THE FACE, BUT DID NOTICE SOME DISCREPANCIES FURTHER POSTERIOR ON THE FACE. THEY CONTINUED TO NAVIGATE, BUT IGS WAS ABORTED DUE TO APPARENT PT INJURY. FURTHER INFO INDICATES THAT THE SINUS ARTERY WAS SEVERED IN PT WITH POSTERIOR BLEEDING BEHIND THE EYE. PT HAD MULTIPLE POST-OP PROCEDURES TO RELIEVE PRESSURE BEHIND THE EYE AS WELL AS ARTERY LIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON PLUS STEREOTACTIC SURGICAL SYSTEM HAW MEDTRONIC NAVIGATION, INC. 9680110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention