BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLESTAR INTEGRATION SYSTEM

    MDR report key: 2081294 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00810
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    January 20, 2010
    Report Date
    January 20, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    LNH
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP REPLACED THE INTERNAL PSU SENSOR CABLE, AS IT WAS DAMAGED. ENGINEERING TESTING BELIEVES THE CAUSE IS ALSO RELATED TO LOW LEVEL SOFTWARE LIBRARY AND NOT ALLOWING THE PROBE AND FRAME TO BE SEEN TOGETHER, WHICH HAS BEEN FIXED IN SOFTWARE UPDATE.

    Description of Event or Problem · 1

    A SITE REPORTED THAT IN THE NORMAL NAVIGATION WINDOW THE TWO UNIT BOXES (BLACK PRF AND PROBE) ARE FREQUENTLY FLASHING BETWEEN RED AND GREEN. IT ALMOST SEEMS LIKE WITH THE NEW POLESTAR SOFTWARE THE "CONE" OF THE CAMERA IS SMALLER AND SO IT MAKES GETTING BOTH THE PROBE AND THE PASSIVE REFERENCE FRAME (PRF) MUCH MORE DIFFICULT TO SEE TOGETHER, ESPECIALLY WHEN ATTEMPTING TO GO AROUND THE SKULL WITH TRACER. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLESTAR INTEGRATION SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING (LNH) LNH MEDTRONIC NAVIGATION, INC. POLESTAR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK