BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 3113530 · Received May 15, 2013

    Report

    Report Number
    1723170-2013-00341
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT. RMA WAS ISSUED. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT END OF THE VERTEK ARM IS LOCKED UP. THIS IS A DOWN REVISION PART. A REPLACEMENT VERTEK ARM HAS BEEN SENT TO THE SITE FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE ARTICULATING ARM DOES NOT LOCK COMPLETELY WHEN TIGHTENING THE HANDLE. THERE WAS NO PATIENT PRESENT WHEN THIS CONCERN WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215539 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1