BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7? INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3379766 · Received October 1, 2013

    Report

    Report Number
    1723170-2013-00783
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    September 3, 2013
    Report Date
    September 3, 2013
    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

    RMA ISSUED. REPLACEMENT RADIOLUCENT ARM SHIPPED TO SITE (B)(4) 2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE FRAME ATTACHMENT PIECE (LOT 130116) HAS DAMAGED THREADS NOT ALLOWING EASY FRAME ATTACHMENT. MECHANICAL FAILURE, SCREW CROSS THREADED, DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE RADIOLUCENT ARTICULATING ARM WAS NOT ATTACHING EASILY WITH THE PASSIVE REFERENCE FRAME. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494951 STEALTHSTATION® I7? INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR