BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIEM PORTABLE SYSTEM

    MDR report key: 1970919 · Received January 5, 2011

    Report

    Report Number
    1723170-2011-00017
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REPLACEMENT CABLE WAS SHIPPED, AND A RMA TO RETURN THE DEFECTIVE CABLE WAS ISSUED. THE CABLE WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE AXIEM COMMUNICATION AND POWER CABLE HAD A CUT IN IT AND THE AXIEM WAS NOT COMMUNICATING. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1