BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLESTAR INTEGRATION SYSTEM

    MDR report key: 1935866 · Received December 3, 2010

    Report

    Report Number
    1723170-2010-00137
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT AVAILABLE AT THE TIME OF THIS REPORT. THE SYSTEM WAS CHECKED TO IDENTIFY THE COMPONENT THAT NEEDED REPLACEMENT. A RMA WAS ISSUED FOR THE RETURNED/REPLACEMENT OF THE RELAY BOX. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAD AN ISSUE WITH THE CAMERA TIMING OUT WHEN USING THE POLESTAR INTEGRATED CAMERA ON A SYNERGY SPINE CASE. USE OF THE SYSTEM WAS CONTINUED WITH NO IMPACT ON 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