BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1980324 · Received February 3, 2011

    Report

    Report Number
    2021898-2011-00025
    Event Type
    Injury
    Date Received
    February 3, 2011
    Report Date
    November 23, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS PATENT AND PASSED SIPHON, REFLUX AND LEAK TESTING. THE DEVICE PERFORMANCE DID NOT MEET ALL ESTABLISHED SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. THE INLET CONNECTOR WAS PARTIALLY CRUSHED, HAD A RADIAL CONSTRICTION IN THE MIDDLE, AND THERE WERE GOUGES ON THE TIP. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED, BUT THE COMPROMISED SHAPE OF THE CONNECTOR MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "IMPROPER USE OF INSTRUMENTS IN THE HANDLING OR IMPLANTATION OF SHUNT PRODUCTS MAY RESULT IN THE CUTTING, SLITTING OR CRUSHING OF COMPONENTS. SUCH DAMAGE MAY LEAD TO LOSS OF SHUNT INTEGRITY, AND NECESSITATE PREMATURE SURGICAL REVISION OF THE SHUNT SYSTEM". A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. 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 THE VALVE WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORT, THE PROXIMAL CATHETER DISLODGED FROM THE VALVE WHILE IMPLANTED IN THE PATIENT, AND THE DOCTOR SUSPECTED THAT A VALVE MALFUNCTION MAY HAVE CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA C31213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK