BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIEM PORTABLE SYSTEM

    MDR report key: 1620151 · Received February 26, 2010

    Report

    Report Number
    1723170-2010-00002
    Event Type
    Other
    Date Received
    February 26, 2010
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE AT THE TIME OF THIS REPORT BUT INFORMATION HAS BEEN REQUESTED. REVISION SURGERY WAS REQUIRED. DEVICE WAS RETURNED TO MANUFACTURER. AFTER HEATING UNIT FOR 10 MINUTES BY COVERING FAN, AMP C PCBA BEGAN TO EXHIBIT HIGH NOISE (APP. 70 DB) IN EMDIAGNOSTICS. FREEZ IT USED ON PCBA OPPOSITE/UNDER ZETEX CHIP CAUSES AN IMMEDIATE DROP TO A MORE NORMAL LOADED NOISE LEVEL (APP. 55 DB). DEVICE WAS REPLACE WITH A DIFFERENT UNIT AT SITE.

    Description of Event or Problem · 1

    AXIEM STOPPED WORKING DURING CASE. IT STATED "AXIEM EMITTER AMPLIFIER NOISE" - "AXIEM SYSTEM HARDWARE IS MALFUNCTIONING TRY REBOOTING THE SYSTEM." SITE SWAPPED TO A SPARE EMITTER AND ISSUE DIDN'T RESOLVE. THE SURGEON CONTINUED BUT DOESN'T THINK THAT HE REMOVED AS MUCH TUMOR AS HE WOULD HAVE DONE. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT AND THAT REPLACEMENT OF THE AXIEM PORTABLE RESOLVED THE ISSUE. ADDITIONAL SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIEM PORTABLE SYSTEM STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION AXIEM PORTABLE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention