BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2020595 · Received February 10, 2011

    Report

    Report Number
    1723170-2011-00103
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. DEVICE MANUFACTURE DATE NOT AVAILABLE AT THIS TIME. SOFTWARE EVALUATION HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    SURGEON REPORTED REGISTRATION RESULTING WITH INACCURACY IN THE TRAJECTORY VIEWS WHILE IN A SPINE PROCEDURE. THE SURGEON STATED THAT POST LUMBAR FLUOROSCOPY MERGE REGISTRATION HE WAS INACCURATE IN TRAJECTORY VIEWS BUT ORTHOGONAL AND FLUORO IMAGES WERE ACCURATE. FOLLOWING TROUBLESHOOTING WITH MEDTRONIC TECHNICAL SERVICES, HE CHANGED THE ORTHOGONAL VIEWS AND DID THE LAST PART OF MERGE AGAIN AND HE WAS THEN ACCURATE. SURGEON OPTED TO CONTINUE THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON PATIENT 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 UNK