BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2973098 · Received February 21, 2013

    Report

    Report Number
    1723170-2012-00710
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE EVALUATION COMPLETED. FINDINGS ARE THAT, AS REPORTED, THE PATIENT TRACKER WAS BUMPED WHICH CHANGED THE TRACKER-TO-PATIENT ORIENTATION. SOFTWARE IS FUNCTIONING AS DESIGNED; DEEMED TO BE A USE ERROR.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN INACCURACY WHILE IN A PROCEDURE. A SUCCESSFUL REGISTRATION WAS DONE AND FOUND TO BE ACCURATE. PROCEDURE CONTINUED AND PATIENT WAS BEING DRAPED WHEN THE PATIENT TRACKER WAS BUMPED UNBEKNOWNST TO THE STAFF. WHILE CHECKING ACCURACY, IT WAS NOTED THAT THEY WERE 1CM INACCURATE MEDIALLY. THE SURGEON COMPENSATED FOR ACCURACY TO COMPLETE CASE WITH THE USE OF THE STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77488 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female