BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4241317 · Received November 10, 2014

    Report

    Report Number
    1723170-2014-01169
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. REPLACEMENT DEVICE SHIPPED TO SITE FOR ISSUE RESOLUTION. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE HANDLE SPINS FREELY AND DOES NOT TIGHTEN THE ARM. THE ARM IS NON-FUNCTIONAL. THE REPORTED EVENT WAS CONFIRMED TO BE CAUSED BY A MECHANICAL FAILURE MODE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE SCREWS WERE STRIPPED ON A NAVIGATION SYSTEM ARTICULATING ARM. 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
    723612 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1