BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA® II VALVE, REGULAR

    MDR report key: 4173587 · Received October 15, 2014

    Report

    Report Number
    2021898-2014-00408
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    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

    THE VALVE WAS PATENT. IT MET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW AND PREIMPLANTATION TESTS. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE, SIPHON, AND REFLUX TESTS. TEARS WERE OBSERVED ON THE TOP OF THE RESERVOIR DOME. 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 WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A STRATA II SHUNT WAS NOT REDUCING A PATIENT'S VENTRICLE SIZE EVEN AT THE LOWEST PRESSURE-LEVEL SETTING OF 0.5. THE SHUNT WAS EXPLANTED AND REPLACED WITH A NEW STRATA II SHUNT. THE PATIENT'S VENTRICLES WERE REPORTED TO HAVE SOMEWHAT REDUCED IN SIZE WITH THE NEW SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654765 STRATA® II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R