BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM¿

    MDR report key: 3037221 · Received April 5, 2013

    Report

    Report Number
    1723170-2013-00253
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS REPORTED TO BE INVOLVED IN THIS REPORTED EVENT. LOT# AND MANUFACTURED DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND WAS ABLE TO GET THE SUCTIONS TO VERIFY BY MANIPULATING THEM IN THE DIVOT WHEN THE HIGH ERROR SHOULD HAVE PREVENTED VERIFICATION. REPRESENTATIVE WAS TRAINED THAT SUCTIONS SHOULD NOT BE MANIPULATED TO VERIFY IN THIS MANNER. SUCTIONS HAVE NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE HAS BEEN HAVING ISSUES VERIFYING THEIR STRAIGHT SUCTIONS FOR NAVIGATION. UPON INVESTIGATION, THE REP FOUND THE SUCTIONS DISPLAYED HIGH VERIFICATION ERRORS BUT WHEN MANIPULATING THE SUCTIONS TO DIFFERENT ANGLES WITHIN THE DIVOT HE WAS ABLE TO GET THEM TO VERIFY. THE REP REPORTED THAT IN ANOTHER CASE THE SURGEON HAD DONE THIS AND THEN FELT INACCURATE BY A FEW MILLIMETERS WHILE NAVIGATING WITH THE SUCTION. THERE WAS NO PATIENT PRESENT FOR THIS REPORTED EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP REVIEW FOUND THAT THE REPORTED EVENT WAS SUBMITTED IN ERROR AND WAS A DUPLICATE OF MDR-1723170-2013-00257.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140519 STRAIGHT SUCTION, AXIEM¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1