BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIEM PORTABLE SYSTEM

    MDR report key: 2013757 · Received February 5, 2011

    Report

    Report Number
    1723170-2011-00087
    Event Type
    Malfunction
    Date Received
    February 5, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE NOT AVAILABLE AT TIME OF THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION ON (B)(6) 2011. THE INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE COMMUNICATION CABLE FOR THE AXIEM PORTABLE SYSTEM WAS CAUSING AN INTERMITTENT CONNECTION. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1