BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3952990 · Received July 23, 2014

    Report

    Report Number
    1723170-2014-00794
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN SUBMITTED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    A SOFTWARE INVESTIGATION WAS COMPLETED AND DETERMINED THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE

    Description of Event or Problem · 1

    A MEDTRONIC MARKETING REPRESENTATIVE REPORTED THAT WHILE IN TEST WITH A NAVIGATION SYSTEM, FRAMELINK SOFTWARE UNEXPECTEDLY EXITED WHEN IN THE STEP TO SELECT A PATIENT. TROUBLE-SHOOTING DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430328 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1