BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II SMALL

    MDR report key: 2833419 · Received October 26, 2012

    Report

    Report Number
    2021898-2012-00358
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MET THE REQUIREMENTS FOR LEAK TESTING, HOWEVER IT WAS NOT PATENT AND WAS OUT OF SPECIFICATION FOR SIPHON, REFLUX, PRE-IMPLANTATION, AND PRESSURE FLOW TESTING DUE TO PROTEINACEOUS DEBRIS INTERFERENCE WITH INTERNAL FLOW CONTROL MECHANISMS. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT PARTICULATE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN AND INTERFERE WITH THE ANTI-SIPHON DEVICE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT IT WAS SUSPECTED THAT THE SHUNT MAY NOT HAVE BEEN PERFORMING OPTIMALLY. THE SHUNT WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization