BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF- CONTOUR SHUNT KIT, REGULAR, MEDIUM PRESSURE

    MDR report key: 3911240 · Received July 2, 2014

    Report

    Report Number
    2021898-2014-00226
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 25, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS PATENT. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT ALSO MET ALL OF THE REQUIREMENTS FOR THE REFLUX, PRESSURE-FLOW, PREIMPLANTATION, AND LEAKAGE TESTS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE IMPLANTATION SURGERY THE VALVE WAS FOUND TO BE CLOGGED BEFORE USE. IT WAS ALSO REPORTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385928 CSF- CONTOUR SHUNT KIT, REGULAR, MEDIUM PRESSURE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 9003 E D25266

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR