BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 3974146 · Received August 1, 2014

    Report

    Report Number
    2021898-2014-00276
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. IT MET ALL OF THE REQUIREMENTS FOR THE SIPHON, PREIMPLANTATION, AND PRESSURE-FLOW TESTS. IT DID NOT MEET REQUIREMENTS FOR THE REFLUX AND LEAKAGE TESTS. A TEAR WAS OBSERVED ON THE TOP SIPHON CONTROL DEVICE MEMBRANE. ANOTHER TEAR WAS OBSERVED ON THE SIPHON CONTROL DEVICE OUTER CASING. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS THAT IMPROPER USE OF INSTRUMENTS IN THE HANDLING OR IMPLANTATION OF SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. 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

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THAT THE VALVE WAS FOUND TO LEAK WHEN THE PHYSICIAN PERFORMED THE PREIMPLANTATION TESTING, AND THAT A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. ACCORDING TO THE REPORT, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451579 STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D42817

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR