BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MNS UNKNOWN VALVE/SHUNT

    MDR report key: 3770699 · Received April 24, 2014

    Report

    Report Number
    2021898-2014-00134
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    July 1, 2013
    Report Date
    March 26, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD BEEN DIAGNOSED WITH PRIMARY INTRACRANIAL HYPERTENSION SINCE THE AGE OF 15. ACCORDING TO THE REPORT, THE PATIENT HAD THEIR FIRST VENTRICULOPERITONEAL SHUNT WHEN THEY WERE 16 AND THEY ARE CURRENTLY ON THEIR FOURTH OR FIFTH SHUNT. THE REPORT STATED THAT THE PATIENT¿S CURRENT SHUNT IS A MEDTRONIC SET-PRESSURE VALVE THAT WAS PLACED IN 2007 AND HAS BEEN SHOWN TO HAVE SLIGHTLY ELEVATED PRESSURES FOR A COUPLE YEARS NOW. REPORTEDLY, THE PRESSURE IS NOT HIGH ENOUGH FOR THE PATIENT¿S NEUROSURGEON TO REPLACE THE SHUNT. ACCORDING TO THE REPORT, THE PATIENT HAS BEEN HAVING TROUBLE WITH THEIR BALANCE AND GAIT OVER THE LAST YEAR OR SO CULMINATING IN FALLING AND BREAKING THEIR WRIST LAST (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249083 MNS UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1