BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE

    MDR report key: 3040322 · Received April 3, 2013

    Report

    Report Number
    2021898-2013-00121
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 1, 2011
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT CAME FROM THE LITERATURE ARTICLE TITLED, "ANALYSIS OF THE RISK OF SHUNT FAILURE OR INFECTION RELATED TO CEREBROSPINAL FLUID CELL COUNT, PROTEIN LEVEL, AND GLUCOSE LEVELS IN LOW-BIRTH-WEIGHT, PREMATURE INFANTS WITH POSTHEMORRHAGIC HYDROCEPHALUS," PUBLISHED IN THE JOURNAL OF NEUROSURGERY: PEDIATRICS 7 (2011) 147-151. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS NOT RETURNED. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS ALSO NOT POSSIBLE, AS A LOT NUMBER WAS NOT PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN A LITERATURE REVIEW BY MEDTRONIC NEUROSURGERY THAT A STRATA VALVE HAD ALLEGEDLY MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136963 UNKNOWN STRATA VALVE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO