BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

    MDR report key: 17523753 · Received August 12, 2023

    Report

    Report Number
    MW5130701
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    April 23, 2013
    Manufacturer
    JOHNSON AND JOHNSON MEDICAL
    Product Code
    JXG
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON MARCH 28, 2013, MEDTRONIC NEUROSURGERY RECEIVED A REPORT FROM (B)(6) HOSPITAL IN CHINA REGARDING AN UNKNOWN MODEL OF ADJUSTABLE HYDROCEPHALUS SHUNT THAT WAS SAID DO BE ALLOWING EXCESS CSF DRAINAGE FROM THE PATIENT AND THAT IT REQUIRED READJUSTMENT. THE DEVICE CATALOG AND LOT NUMBERS WERE NOT PROVIDED. ON (B)(6) 2013, THE DEVICE LISTED IN THE REPORT WAS CONFIRMED TO BE A JOHNSON AND JOHNSON BRAND DEVICE, AND IS NOT A PRODUCT THAT IS MANUFACTURED OR DISTRIBUTED BY MEDTRONIC NEUROSURGERY. IT IS UNKNOWN IF THE REPORTED DEVICE IS MARKETED FOR SALE IN THE UNITED STATES. AS THE REPORT WAS DEEMED ERRONEOUS, MEDTRONIC NEUROSURGERY WILL NOT FILE FORM FDA 3500A WITH RESPECT TO THIS EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193051 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG JOHNSON AND JOHNSON MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown