BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 2113778 · Received June 2, 2011

    Report

    Report Number
    2021898-2011-00123
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS FULLY ADJUSTABLE AND ALL PERFORMANCE LEVELS COULD BE SET ON THE FIRST ATTEMPT. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. THE VALVE WAS PATENT AND PASSED SIPHON TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR REFLUX AND LEAK TESTING DUE TO A TEAR IN THE SIDE OF THE DELTA CHAMBER. THE DEVICE MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. PROTEINACEOUS DEBRIS WAS FOUND ON THE INTERIOR OF THE VALVE, PARTICULARLY IN THE DELTA CHAMBER. 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 WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A VALVE REVISION OCCURRED. ACCORDING TO THE REPORT THE VALVE BECAME STUCK AT 0.5 AND WOULD NOT BUDGE FROM THAT PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R