BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 6031126 · Received October 14, 2016

    Report

    Report Number
    2021898-2016-00373
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    March 3, 2013
    Report Date
    September 16, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. LITERATURE ARTICLE: A SIMPLE PROTOCOL TO PREVENT EXTERNAL VENTRICULAR DRAIN INFECTIONS AUTHORS: ALEXANDER C. FLINT, MD, PHD, VIVEK A. RAO, MD, NATALIE C. RENDA, MD, BONNIE S. FAIGELES, NP, MPH, TODD E. LASMAN, MD, WILLIAM SHERIDAN, MD NEUROSURGERY 72:993¿999, 2013 DOI: 10.1227/NEU.0B013E31828E8DFD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY IDENTIFIED THE FOLLOWING INFORMATION UPON REVIEW OF SCIENTIFIC LITERATURE: A TOTAL OF 14 PATIENTS EXPERIENCED INFECTIONS WHEN USING A NON-ANTIBIOTIC-IMPREGNATED CATHETER. ACCORDING TO THE ARTICLE, THE 14 INFECTIONS OCCURRED A MEDIAN OF 8 DAYS AFTER PLACEMENT. THE ARTICLE NOTED THAT 9 PATIENTS EXPERIENCED VENTRICULITIS. AFTER THE INTRODUCTION OF THE INFECTION CONTROL PROTOCOL (USING A RIFAMPIN/MINOCYCLINE㉍PREGNATED CATHETER), A SINGLE INFECTION OCCURRED AT 11 DAYS AFTER PLACEMENT. REPORTEDLY, THE SINGLE PATIENT WITH AN INFECTION REMOVED THEIR OWN EXTERNAL VENTRICULAR DRAIN (EVD) APPROXIMATELY TWO DAYS BEFORE DEVELOPING CULTURE-POSITIVE VENTRICULITIS. ORGANISMS CULTURED FROM CEREBROSPINAL FLUID (CSF) IN THE BASELINE PERIOD WERE STAPHYLOCOCCUS EPIDERMIDIS, COAGULASE-NEGATIVE STAPHYLOCOCCUS, STAPHYLOCOCCUS CAPITIS, STAPHYLOCOCCUS AUREUS, STENOTROPHOMONAS MA LTOPHILIA, VANCOMYCIN-RESISTANT ENTEROCOCCUS, CANDIDA SPECIES, AND EXOPHIALA SPINIFERA. REPORTEDLY, THE ORGANISM CULTURED FROM CSF IN THE 1 POSITIVE CASE IN THE EVD INFECTION CONTROL PROTOCOL PERIOD WAS STREPTOCOCCUS PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680500 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention