BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIEM CRANIAL NON-INVASIVE TUMOR RESECTION KIT

    MDR report key: 3821869 · Received May 20, 2014

    Report

    Report Number
    1723170-2014-00590
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    December 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: IT WAS DISCOVERED ON 11/12/2015, THAT THE INFORMATION SUBMITTED ON MDR 1723170-2014-00590 FOLLOW UP 1, WAS ACCIDENTALLY SUBMITTED UNDER THE INCORRECT MDR NUMBER AND WAS THEREFORE ERRONEOUS TO THIS MDR. PLEASE DISREGARD THE INFORMATION SUBMITTED ON 1723170-2014-00590 FOLLOW UP #1.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE WAS UNAVAILABLE AS THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. DEVICE DISCARDED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. A WORK-AROUND FOR RECOVERING THE PATIENT DATABASE HAS BEEN COMMUNICATED TO THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A PATIENT TRACKER STOPPED WORKING DURING NAVIGATION OF A TUMOR RESECTION SURGERY. THE TRACKER WAS WORKING FOR REGISTRATION AND DURING NAVIGATION INITIALLY BUT STOPPED TRACKING AFTER THE CABLE FOR THE PATIENT TRACKER WAS STEPPED ON. THE GREEN LED WAS LIT ON THE AXIEM BOX BUT IT COULD NOT BE TRACKED REGARDLESS OF EMITTER POSITION. THE INSTRUMENT TRACKER WAS ABLE TO BE TRACKED WITHOUT ANY ISSUES. THE PATIENT TRACKER WAS CONNECTED TO ANOTHER PORT AND SOFTWARE WAS REBOOTED WITHOUT RESOLUTION. THE SURGEON CHOSE TO DISCONTINUE NAVIGATION AND COMPLETE THE SURGERY WITHOUT NAVIGATION. THERE WAS NO IMPACT TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300338 AXIEM CRANIAL NON-INVASIVE TUMOR RESECTION KIT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR