BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050131 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00579
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT WAS PRESENT. MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM ON SITE. SHE WAS UNABLE TO DUPLICATE THE ISSUE AND THIS ISSUE HAS NOT RECURRED.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THAT THE STEALTH SYSTEM IS TURNING ITSELF OFF WITHOUT WARNING. 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 NONE