BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050102 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00555
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 25, 2008
    Report Date
    September 29, 2008
    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

    OVERLY FULL HARD DRIVE CAUSED ISSUES IN THE SOFTWARE. THE MEDTRONIC REP VISITED THE SITE AND REMOVED EXCESS EXAMS FROM THE SYSTEM TO CLEAR OUT HARD DRIVE SPACE AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THE SYSTEM'S MEMORY GETTING TOO FULL RESULTING IN ISSUES IN SLOW SOFTWARE PERFORMANCE. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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