BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA® II VALVE, SMALL

    MDR report key: 4090300 · Received September 15, 2014

    Report

    Report Number
    2021898-2014-00369
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    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 AND INSPECTED 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 VALVE WAS PATENT. IT MET ALL OF THE REQUIREMENTS FOR THE SIPHON, REFLUX, LEAKAGE, PREIMPLANTATION, AND PRESSURE-FLOW TESTS. ADDITIONALLY, THERE WERE NO TEARS OBSERVED ON THE VALVE. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE VERIFIED BY LABORATORY PERSONNEL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STRATA VALVE WAS FOUND TO HAVE TEAR ON IT BEFORE IMPLANTATION. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568889 STRATA® II VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D52342

    Patients

    Seq Age Sex Outcome Treatment
    1