BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIEM PORTABLE SYSTEM

    MDR report key: 2081207 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00802
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    May 22, 2009
    Report Date
    June 1, 2009
    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

    DEVICE MFR DATE UNK. NO INFO COLLECTED AT THE TIME OF THE INCIDENT. UNABLE TO DO ANY FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A SITE REPORTED, THEY EXPERIENCED AN AXIEM SYSTEM CRASH DURING A SHUNT PROCEDURE. THERE WAS NO IMPACT ON PT OUTCOME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK