BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR PROBE TIP

    MDR report key: 3191207 · Received June 26, 2013

    Report

    Report Number
    1723170-2013-00477
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT SELECTED IN ERROR ON THE INITIAL 3500A. SHOULD ONLY BE PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE.RMA ISSUED. REPLACEMENT LUMBAR PROBE SHIPPED TO SITE 05/31/2013. MEDTRONIC INSPECTION OF RETURNED SUSPECT DEVICE FINDS THAT AS REPORTED, THE TIP OF THE INSTRUMENT IS BENT AND TWISTED. THERE ARE ALSO WEAR RINGS AT THE BACK END OF THE INSTRUMENT CAUSING A TIGHT FIT INTO A NAVLOCK. PHYSICAL DAMAGE, DEFORMATION, DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A LUMBAR PROBE WAS DAMAGED, BENT. 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
    290800 LUMBAR PROBE TIP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120803

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR