BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK THORACIC PROBE

    MDR report key: 2240817 · Received August 16, 2011

    Report

    Report Number
    1723170-2011-01293
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 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 MFR DATE IS NOT AVAILABLE AT THIS TIME. INSTRUMENT RETURNED TO THE MFR. INVESTIGATION FINDS THE TIP OF THE PROBE IS BENT. REPORTED PT ANATOMY CONTRIBUTED TO THE DAMAGE OF THE INSTRUMENT. A REPLACEMENT PART WAS SHIPPED (B)(4) 2011.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHILE IN A PROCEDURE, THE SURGEON BENT THE TIP OF THE NAVLOCK THORACIC PROBE WHILE ATTEMPTING TO ADVANCE TAPS AND SCREWS. IT WAS DETERMINED THAT THE PT'S BONE WAS SO SLEROTIC AND DENSE THAT ADVANCING TAPS WAS PROBLEMATIC. PT WAS NOT HARMED AND CASE PROCEEDED AS PLANNED USING THE STEALTHSTATION S7 SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVLOCK THORACIC PROBE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 110503

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR