BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1961563 · Received December 27, 2010

    Report

    Report Number
    1723170-2010-00224
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    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 PATIENT EXAMS WERE RETURNED FOR EVALUATION AND THE SOFTWARE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD NOTIFIED HIM THAT THEY WERE DOING A REGISTRATION WITH TOUCH-N-GO IN MACH CRANIAL AND THE REGISTRATION WAS FLIPPED LEFT/RIGHT. THE SURGEON THEN USED A POINTMERGE REGISTRATION AND THE CASE WAS CONTINUED WITH 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 85 YR