BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JXG- SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

    MDR report key: 2877397 · Received December 14, 2012

    Report

    Report Number
    2021898-2012-00427
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVAL OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT STATED IN (B)(4) THAT SHE HAD FOUR REVISIONS AND REPLACEMENTS OF SHUNT SYSTEMS SINCE HER FIRST ONE WAS PLACED IN 2000. ACCORDING TO THE REPORT, 2008 SHE HAD A MALFUNCTION AND EMERGENT REPLACEMENT OF A SHUNT THAT WAS PLACED IN 2006. ALLEGEDLY, THE TUBING DISCONNECTED. RETRACTED AND RECOILED CAUSING FOUR LARGE POCKETS OF CSF TO BUILD; THE SMALLEST OF THE FOUR WAS LOCATED IN THE CENTER OF HER STERNUM AND WAS THE SIZE OF A TENNIS BALL. THE REPORT STATED THAT THE SURGERY REQUIRED MAJOR ABDOMINAL REPAIR. ACCORDING TO THE REPORT, HER CURRENT SHUNT CAUSES MAJOR ABDOMINAL PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR