BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA® II VALVE, REGULAR

    MDR report key: 3922623 · Received July 9, 2014

    Report

    Report Number
    2021898-2014-00232
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT, AND MET THE REQUIREMENTS FOR SIPHON, PRESSURE-FLOW, AND PREIMPLANTATION TESTING. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR REFLUX TESTING DUE TO THE PRESENCE OF PROTEINACEOUS DEBRIS WITHIN THE VALVE, OR FOR LEAK TESTING DUE TO A TEAR IN THE SILICONE OVER THE RESERVOIR. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND/OR SIPHONING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN THOUGHT THE PATIENT REQUIRED A HIGHER PRESSURE THAN THE VALVE WAS CAPABLE OF PROVIDING, AND THAT IT WAS THEREFORE EXPLANTED AND REPLACED WITH DIFFERENT PRODUCT. ACCORDING TO THE REPORT, THE PATIENT DID NOT INCUR AN INJURY AND WAS DOING WELL FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401966 STRATA® II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D57401

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R