BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6457388 · Received April 4, 2017

    Report

    Report Number
    1723170-2017-01484
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    March 7, 2017
    Report Date
    April 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A MEDTRONIC REPRESENTATIVE REPORTED THAT RESTARTING THE IMAGING SYSTEM AND CLEARING THE TEMP FILE DID NOT RESOLVE THE REPORTED ISSUE. CORRECTION: THE UNIQUE DEVICE IDENTIFICATION (UDI) HAS BEEN UPDATED TO THE PROPER VALUE. IT WAS REPORTED THAT THE SURGERY WAS ABORTED AND THAT THE PATIENT WAS UNDER ANESTHESIA WHEN THE REPORTED ISSUE OCCURRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LOGS WERE REVIEWED AND REVEALED THAT THE PATIENT OID ALREADY EXISTS IN THE PATIENT DATABASE, WHICH PREVENTS THE PATIENT FROM BEING ADDED AGAIN. DELETING PATIENT 1723170 MAY RESOLVE THE ISSUE. INSTRUCTIONS WERE THEREFORE PROVIDED FOR DELETING FILE. ATTEMPTS HAVE BEEN MADE FOR RESOLUTION STATUS. NO ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS ADDRESSED IN THE NEWEST VERSION OF SOFTWARE WHICH INCORPORATED A FIX FOR THIS ANOMALY.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE. PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. ONSITE INVESTIGATION WAS PREFORMED AND THE FIELD REPRESENTATIVE WAS ABLE TO REPLICATE THE REPORTED EVENT. SYSTEM LOGS WERE SENT TO THE TECHNICAL SERVICES TEAM FOR REVIEW. TECHNICAL SERVICES TEAM COULD NOT REPLICATE THE ISSUES BASED ON THE SYSTEM LOGS MADE AVAILABLE, THEY WERE ABLE TO LOAD AND TRANSFER PROFILES WITHOUT ISSUES. NO PARTS WERE RETURNED OR REPLACED AND NO FURTHER ISSUES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SOFTWARE OF THE NAVIGATION SYSTEM WAS UPDATED TO RESTORE FUNCTIONALITY. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN AN ELECTRODE AND PROBE PLACEMENT PROCEDURE, THEY TRIED TO IMPORT A PATIENT PROFILE FROM THE PLANNING STATION AND AN ERROR MESSAGE APPEARED NOT ALLOWING THEM TO LOAD OR SEE THE PATIENT PROFILE. THE MESSAGE READ 'THIS PATIENT IS ALREADY LOADED. PLEASE, DELETE IT AND LOAD IT AGAIN'. THEY COULDN'T SEE THE PATIENT ON THE PATIENT LIST, THE ERROR MESSAGE PERSISTED EVEN AFTER DELETING ALL PATIENT PROFILES THEY TRIED LOADING THE PATIENT PROFILE VIA USB BUT THE SAME ERROR MESSAGE APPEARED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF MORE THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239174 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7

    Patients

    Seq Age Sex Outcome Treatment
    1