BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1813642 · Received August 12, 2010

    Report

    Report Number
    1723170-2010-00038
    Event Type
    Other
    Date Received
    August 12, 2010
    Date of Event
    June 11, 2008
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC NAVIGATION WAS INITIALLY MADE AWARE OF THIS EVENT OF (B)(6) 2010. FURTHER INVESTIGATION NECESSARY.

    Description of Event or Problem · 1

    MEDTRONIC NAVIGATION WAS MADE AWARE OF THIS EVENT ON (B)(6) 2010 VIA A LEGAL NOTICE FROM (B)(6). THE INFORMATION PROVIDED SUGGESTS THE POSSIBILITY OF A MALFUNCTION, ALTHOUGH INSUFFICIENT INFORMATION WAS PROVIDED TO MAKE A DEFINITIVE DETERMINATION. MEDTRONIC NAVIGATION IS FILING IN THE ABSENCE OF INFORMATION TO RULE-OUT A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other