BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 2172129 · Received June 24, 2011

    Report

    Report Number
    1723170-2011-01150
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED. RMA SUBMITTED FOR A REPLACEMENT TIU TO BE SENT TO SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT AFTER ABOUT TWO HOURS OF THE TRIA SYSTEM BEING ON, THE SITE LOST TRACKING OF BOTH ACTIVE AND PASSIVE INSTRUMENTS. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TRIA NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TRIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1