BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 3894410 · Received June 25, 2014

    Report

    Report Number
    2021898-2014-00213
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K802100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WAS CONNECTED TO A VENTRICULAR DRAINAGE SYSTEM ON (B)(6) 2014, AND THE LUMBAR DRAINAGE SYSTEM WITH 2% LIDOCAINE FOR LOCAL ANESTHESIA ON (B)(6) 2014. ACCORDING TO THE REPORT, THE PHYSICIAN INSERTED THE NEEDLE APPROXIMATELY 5 CM AT THE SITE OF THE L4/5 VERTEBRAL SPACE, AND THAT THE CORE OF THE NEEDLE WAS REMOVED AFTER A SENSE OF BREAKTHROUGH WAS FELT AND THAT THERE WAS AN OUTFLOW OF YELLOW COLORED CEREBROSPINAL FLUID (CSF). ACCORDING TO THE REPORT, THE CATHETER WAS PLACED APPROXIMATELY 15 CM INSIDE THE SPACE AND ITS PATENCY WAS CHECKED PRIOR TO REMOVING THE PUNCTURE NEEDLE AND BEING SECURED. THE REPORT STATES THAT THERE WAS NO DISCOMFORT DURING OR AFTER THE SURGERY. ACCORDING TO THE REPORT, FOUR HOURS FOLLOWING THE SURGERY THE PHYSICIAN STOPPED THE VENTRICULAR DRAINAGE AND SET THE LUMBAR DRAINAGE TO A RATE OF 200 ML/DAY. THE REPORT STATES THAT TESTING OF THE CSF SHOWED THAT THE CELL COUNT WAS 22400*106/L, YELLOW, AND THAT THERE WAS NO CLOTTING. ACCORDING TO THE REPORT, THE PHYSICIAN ATTRIBUTED THE RESULTS OF THE CSF TESTING TO INTRACRANIAL INFECTION, AND TREATED THE PATIENT WITH VANCOMYCIN, CEFEPIME, CHLORAMPHENICOL BY INTRAVENOUS Q8H, AND WITH VANCOMYCIN BY INTRATHECAL INJECTION. THE REPORT STATES THAT THE PATIENT WAS DISCHARGED PRIOR TO THE RESOLUTION OF THE INFECTION AT THE REQUEST OF THE PATIENTS¿ FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370806 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 207141801

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention