BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM

    MDR report key: 5985696 · Received September 28, 2016

    Report

    Report Number
    2021898-2016-00353
    Event Type
    Injury
    Date Received
    September 28, 2016
    Report Date
    August 29, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC 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 EDMS DEVICES ARE 100% TESTED AT THE TIME OF MANUFACTURE. LITERATURE ARTICLE: THE STUDY OF USING TWO DIFFERENT DRAIN TUBE FOR TWO-VENTRICLE DRAINAGE IN TREATMENT OF PRIMARY INTRAVENTRICULAR HEMORRHAGE ZHU J, LI Q, SI F, YIN SF, WANG QX, SONG CY JOURNAL OF TAISHAN MEDICAL COLLEGE 2014 35(2): 120-122. 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.

    Additional Manufacturer Narrative · 1

    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 4 PATIENTS EXPERIENCED AN INTRACRANIAL INFECTION AND HAD A BODY TEMPERATURE OVER 38C, A RIGID NECK, AND ELEVATED WHITE CELL COUNT IN CEREBROSPINAL FLUID. THE ARTICLE STATED THAT ONE OF THE PATIENTS DEVELOPED HYDROCEPHALUS AFTER REMOVAL OF THE DEVICE AND REQUIRED A VENTRICULOPERITONEAL SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634355 UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R