BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 3037019 · Received March 29, 2013

    Report

    Report Number
    2021898-2013-00110
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    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

    DURING OUR INVESTIGATION, MEDTRONIC NEUROSURGERY RECEIVING A REPORT INDICATING THAT THE LEAKAGE SITE WAS ON THE CATHETER COMPONENT OF THE DEVICE. THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO LEAK DURING THE OPERATION, AND THAT IT WAS REPLACED TO COMPLETE THE PROCEDURE. NO ADVERSE IMPACT OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130419 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 12162202

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR