BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLESTAR INTEGRATION SYSTEM

    MDR report key: 1950051 · Received December 7, 2010

    Report

    Report Number
    1723170-2010-00149
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE SITE. THE REPORTED ISSUE WAS NOT AVAILABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SYSTEM WAS FULLY FUNCTIONAL AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES. INFO WAS PROVIDED TO THE FIELD REP REGARDING THE CORRECT ORDER OF POWERING ON THE SYSTEMS.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE SCREEN WAS FLICKERING, THE MOUSE WAS FROZEN, AND TOUCHSCREEN WAS NOT WORKING. USE OF THE SYSTEM WAS CONTINUED DURING THE SURGERY WITH NO NEGATIVE IMPACT TO THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STEALTHSTATION TRIA NAVIGATION SYSTEM