BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081107 · Received April 14, 2011

    Report

    Report Number
    1723170-2011-00793
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 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

    SOFTWARE INVESTIGATION CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE MACH CRANIAL APPLICATION EXITED DURING REGISTRATION ON TWO SEPARATE ATTEMPTS. FIRST EXIT OCCURRED AFTER STORING 10 POINTS FOR POINTMERGE. RE-STARTED THE APPLICATION AND POINTS WERE NO LONGER STORED. PROCEEDED TO DO TOUCH-N-GO REGISTRATION AND SOFTWARE EXITED AGAIN. RE-STARTED APPLICATION A THIRD TIME, TOUCH-N-GO REGISTRATION WAS SUCCESSFUL AND CASE PROCEEDED AS PLANNED. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT 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 34 YR