BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081309 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00800
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    May 11, 2009
    Report Date
    May 11, 2009
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION AS NO PATIENT WAS PRESENT IN THIS CONCERN. MEDTRONIC REP TESTED SYSTEM AND IT DID NOT SHOW ANY PARTICULAR DEFECTS. SYSTEM IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A REGULAR SERVICE VISIT A SURGEON CLAIMED A LACK OF ACCURACY WITH THE TREON SYSTEM. THIS EVENT DIDN'T OCCUR DURING SURGERY AND NO PATIENT 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