BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3884292 · Received June 19, 2014

    Report

    Report Number
    1723170-2014-00661
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC FIELD REPRESENTATIVE REPLACED THE CAMERA POWER/COMMUNICATION CABLE. THIS RESOLVED THE ISSUE. THE SUSPECT CABLE WAS DESTROYED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. SUSPECT PART NOT RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED A NAVIGATION SYSTEM CAMERA THAT IS NOT FUNCTIONING PROPERLY DURING THE NAVIGATION TASK. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360075 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1