BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTA DISPOSABLE DRAINAGE SYSTEM

    MDR report key: 1909001 · Received November 18, 2010

    Report

    Report Number
    2021898-2010-00304
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    February 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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 INFO. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED FAILURE RATES WERE WITHIN EXPECTED RANGES FOR EVD AND ELD PROCEDURES. LEVERSTEING-VAN HALL MA, HOPMANS TEM, ET AL. A BUNDLE APPROACH TO REDUCE THE INCIDENCE OF EXTERNAL VENTRICULAR AND LUMBAR DRAIN-RELATED INFECTIONS. JOURNAL OF NEUROSURG 2010; 112:345-353.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 337 PATIENTS WITH 426 EXTERNAL VENTRICULAR OR LUMBAR DRAINS, CONSISTING OF MEDTRONIC EXACTA DRAINAGE AND MONITORING SYSTEMS AND UNKNOWN CATHETERS. THE SOURCE LITERATURE REPORTED 34 PATIENTS WITH DRAIN RELATED INFECTIONS, 3 OF WHICH DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death| H| R