BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 11646761 · Received April 11, 2021

    Report

    Report Number
    2021898-2021-00086
    Event Type
    Injury
    Date Received
    April 11, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 11, 2021
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BERNS, J., PRIDDY, B., BELAL, A., SEIBOLD, R. D., ZIELES, K., & JEA, A. (2021). STANDARDIZATION OF CEREBROSPINAL FLUID SHUNT VALVES IN PEDIATRIC HYDROCEPHALUS: AN ANALYSIS OF COST, OPERATIVE TIME, LENGTH OF STAY, AND SHUNT FAILURE.  JOURNAL OF NEUROSURGERY. PEDIATRICS, 1¿6. HTTPS://DOI.ORG/10.3171/2020.8.PEDS20477. MEDTRONIC RECEIVED A LITERATURE ARTICLE IN WHICH THE AIM WAS TO EVALUATE NEW CSF DIVERSION SHUNTS, AS WELL AS SHUNT REVISIONS REQUIRING A NEW VALVE, OR A NEW VALVE AND AT LEAST A NEW PROXIMAL OR DISTAL CATHETER OVER A 1-YEAR PERIOD FROM JANUARY 1, 2016, TO DECEMBER 31, 2016. 181 SHUNT SURGERIES WERE PERFORMED, IN WHICH THE AVERAGE AGE OF THE PATIENT WAS 6.12 YEARS OLD, CONSISTING OF 61 BOYS AND 26 GIRLS. IN THIS ARTICLE 10 SHUNTS WERE INDICATED FOR REVISION WITHIN 12 MONTHS AFTER INDEX SURGERY DUE TO INFECTION, AND 29 SHUNTS DUE TO SHUNT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544334 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention