BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APT DRIVER

    MDR report key: 2150829 · Received June 21, 2011

    Report

    Report Number
    1723170-2011-01123
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. INVESTIGATION FOUND THAT THE DRIVER ACCEPTS HANDLE AND INSTRUMENTS WITHOUT ISSUE. THE ROTATION IS NORMAL. NO PROBLEM FOUND. ISSUE COULD NOT BE DUPLICATED. REPLACEMENT PART SHIPPED ON 05/25/2011.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE WAS UNABLE TO REMOVE THE PROBE DURING A PROCEDURE BECAUSE THE EGG HANDLE WOULD NOT FIT ON THE AWL/PROBE/TAP (APT) DRIVER. THEY PUT IT DIRECTLY ON THE PROBE TO REMOVE IT. TRACKING WASN'T NEEDED AT THIS POINT BECAUSE THEY WERE JUST BACKING IT OUT OF THE PT. SURGEON COMPLETED THE SURGERY WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APT DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 343588

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR