BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿ PLANNING STATION

    MDR report key: 3103319 · Received May 9, 2013

    Report

    Report Number
    1723170-2013-00331
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFORMATION. THE SOFTWARE INVESTIGATION FOUND THAT THERE WAS AN ISSUE WITH PREDICTED ACCURACY IN THE LOOK-AHEAD VIEW. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. INSTRUCTIONS WERE PROVIDED TO THE ONSITE REPRESENTATIVE ON HOW TO CHANGE THE SYSTEM DEFAULT SETTINGS WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THE LOOKAHEAD VIEW DISPLAYED A VALUE OF 8MM WHEN 4MM WAS SELECTED IN FRAMELINK 5.4. THIS OCCURRED PRE-OPERATIVELY AND DID NOT IMPACT THE DBS PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202926 STEALTHSTATION® S7¿ PLANNING STATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7 PLANNING STATION

    Patients

    Seq Age Sex Outcome Treatment
    1