BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER WITH BIOGLID

    MDR report key: 3873518 · Received June 14, 2014

    Report

    Report Number
    2021898-2014-00201
    Event Type
    Injury
    Date Received
    June 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT MATCHED TO INFORMATION PREVIOUSLY RECEIVED BY MEDTRONIC NEUROSURGERY. THE CORRESPONDING AUTHOR DID NOT HAVE ADDITIONAL INFORMATION REGARDING THE EVENT. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4). RS TUBBS, M MUHLEMAN, M LOUKAS, AA COHEN-GADOL.VENTRICULOPERITONEAL SHUNT MALFUNCTION FROM CEREBROSPINAL FLUID EOSINOPHILIA IN CHILDREN: CASE-BASED UPDATE. CHILDS NERV SYST (2012) 28:345¿348.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTED EVENTS WERE FOUND DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE STATES THAT THE CATHETER WAS IMPREGNATED WITH ANTIBIOTIC SOLUTION PRIOR TO BEING PLACED. ACCORDING TO THE ARTICLE, THE PATIENT MADE AN UNEVENTFUL RECOVERY AND WAS DISCHARGED ON POSTOPERATIVE DAY ONE. THE ARTICLE STATES THAT TWO WEEKS LATER, THE PATIENT PRESENT TO THE EMERGENCY DEPARTMENT WITH EMESIS AND HEADACHE. ACCORDING TO THE ARTICLE, A SHUNT TAP REVEALED ALMOST NO PROXIMAL FLOW AND CSF EOSINOPHILIA OF GREATER THAN 80%. THE ARTICLE STATES THAT INFECTION WAS SUSPECTED AND THAT THE SHUNT WAS REVISED, AND THAT CSF SAMPLED THREE DAYS POST REVISION SHOWED RESOLUTION OF THE PATIENT¿S EOSINOPHILIA. ACCORDING TO THE ARTICLE, AFTER EIGHT DAYS OF CONTINUED NEGATIVE RESULTS FOR CSF INFECTION, THE PATIENT¿S VENTRICULOPERITONEAL WAS REPLACED. THE ARTICLE STATES THAT FIVE YEARS POSTOP, THERE HAVE BEEN NO SIGNS OR SYMPTOMS OF CSF SHUNT OBSTRUCTION OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351849 UNKNOWN CATHETER WITH BIOGLID SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY - UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR Hospitalization| R