BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 3241154 · Received July 22, 2013

    Report

    Report Number
    1723170-2013-00537
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT VERTEK ARM WAS RETURNED FOR FURTHER ANALYSIS. AS REPORTED, THE VERTEK ARM WAS FOUND TO BE SLIGHTLY LOOSE HAVING FAILED THE FORCE TEST AT 11 LBS, SHOULD BE AT LEAST 14 LBS. COMPLAINT CONFIRMED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT VERTEK ARM SHIPPED TO SITE. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A VERTEK ARM THAT REMAINS LOOSE WHEN TIGHTENED AND IS CANNOT BE LOCKED DOWN PROPERLY. THIS WAS NOT DISCOVERED DURING A SURGERY, THE DEVICE IS NOT IN USE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340731 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1