BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR CATHETER, 24CM, OPEN TIP

    MDR report key: 1001641 · Received February 18, 2008

    Report

    Report Number
    2021898-2008-00042
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 28, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL TIP OF THE RETURNED CATHETER IS SHEARED OFF AT A SMOOTH ANGLE. JUST PROXIMAL TO THE BREAK, THERE IS ANOTHER, SMALLER NICK IN THE CATHETER. DAMAGE TO THE CATHETERS CAN OCCUR WHEN THE NEEDLE AND CATHETER ARE NOT REMOVED SIMULTANEOUSLY. THE NEEDLE MAY NICK THE CATHETER AND CAUSE IT TO TEAR. THIS POSSIBILITY IS ADDRESSED IN OUR PRODUCT LABELING. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR CATHETER, 24CM, OPEN TIP 84JXG JXG MEDTRONIC NEUROSURGERY NA C06046

    Patients

    Seq Age Sex Outcome Treatment
    1