BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA OR DELTA VALVES

    MDR report key: 2196950 · Received August 4, 2011

    Report

    Report Number
    2021898-2011-00177
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    November 4, 2010
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED LIMITED INFO. THE CONTACT AUTHOR HAS NOT REPLIED TO REQUESTS FOR ADDITIONAL INFO ABOUT THE DEVICES. THIS ARTICLE COULD NOT BE MATCHED TO ANY INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE, EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS LOT NUMBERS WERE NOT PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. APPELGREN, TOBAIS, ZETTERSTRAND, S, ELFVERSSON, J, AND NILSSON, D. LONG-TERM OUTCOME AFTER TREATMENT OF HYDROCEPHALUS IN CHILDREN. PEDIATRIC NEUROSURGERY 2010;46:221-226.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE INVOLVED 76 VENTRICULAR PERITONEAL SHUNT SURGERIES, 42 OF WHICH USED STRATA VALVES, AND 32 OF WHICH USED DELTA VALVES. FIFTY EIGHT PERCENT OF THE SHUNT SURGERIES FAILED OVER AN AVERAGE FOLLOW-UP TIME OF 4.7 YEARS, AND 17 PERCENT OF PTS DEVELOPED AN INFECTION. THE ARTICLE DID NOT COMMENT ON HOW MANY MEDTRONIC VALVES RESULTED IN REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA OR DELTA VALVES JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 DA Hospitalization| R