BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK EXTERNAL DRAINAGE SYSTEM

    MDR report key: 1910378 · Received November 18, 2010

    Report

    Report Number
    2021898-2010-00305
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    February 1, 2008
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE AND PT INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFORMATION ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED FAILURE RATES WERE WITHIN EXPECTED RANGES FOR EVD PROCEDURES. HOEFNAGLE D, DAMMERS R, ET AL RISK FACTORS FOR INFECTIONS RELATED TO EXTERNAL VENTRICULAR DRAINAGE. ACTA NEUROCHIRURG 2008; 150: 209-214.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 228 PTS WITH EXTERNAL VENTRICULAR DRAINS, CONSISTING OF MEDTRONIC EXTERNAL CSF DRAINAGE SYSTEMS AND UNK CATHETERS. THE SOURCE LITERATURE REPORTED 53 PTS WITH EVD-RELATED INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK EXTERNAL DRAINAGE SYSTEM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R