BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, SMALL

    MDR report key: 2041236 · Received March 30, 2011

    Report

    Report Number
    2021898-2011-00072
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT AND PASSED SIPHON TESTING. THE VALVE DID NOT MEET THE REQUIREMENTS FOR REFLUX AND LEAK TESTING DUE TO A TEAR IN THE TOP OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THIS DAMAGE PRECLUDED PRESSURE-FLOW AND PREIMPLANTATION TESTING. 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 MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT, AFTER IMPLANTATION, THE DOCTOR ALLEGED THAT THERE WERE DILATION OF THE CEREBRAL VENTRICLES, LEAKAGE OF SPINAL FLUID, AND PROGRESSION OF EXTERNAL HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R