BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050136 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00609
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO, AS NO PT WAS INVOLVED IN THIS CONCERN. PER RMA, A REPLACEMENT COMPUTER WAS SENT TO SITE. COMPUTER NOT RECEIVED FOR DISPOSITION AS OF YET, BUT REPLACING IT RESOLVED THE FREEZING ISSUE. SOFTWARE APPLICATION IS NOT AN ISSUE.

    Description of Event or Problem · 1

    SITE CALLED TO REPORT DESPITE HAVING ONLY 3 EXAMS ON THE SYSTEM, IT IS REALLY SLOW AND FREEZING DURING USE. 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