BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 4093693 · Received September 16, 2014

    Report

    Report Number
    1723170-2014-00979
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED ON 09/25/2014 THAT THE DAMAGED CABLE WAS DISCARDED AND REPLACED WITH A THIRD PARTY'S CABLE. THE BIOMED STAFF AT THE SITE WAS PREVIOUSLY INFORMED THAT 3RD PARTY PARTS ARE NOT APPROVED FOR USE ON MEDTRONIC NAVIGATION SYSTEMS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, BIOMED ENGINEER, REPORTED A NAVIGATION SYSTEM POWER CABLE THAT WAS DAMAGED. THE CABLE WAS FOUND WITH A PORTION OF THE INSULATION DAMAGED AND HAD BEEN MENDED USING ELECTRICAL TAPE; NO LIVE WIRES WERE EXPOSED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573484 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1