BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 VALVE, SMALL

    MDR report key: 3093710 · Received May 1, 2013

    Report

    Report Number
    2021898-2013-00156
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    February 17, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INLET CONNECTOR OF THE RETURNED VALVE WAS BROKEN AND MISSING. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE DAMAGE PRECLUDED PATENCY, LEAK, SIPHON, REFLUX, PRESSURE-FLOW AND PREIMPLANTATION TESTING. ALL PERFORMANCE LEVELS COULD BE SET IN A SINGLE ATTEMPT. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR AS WELL AS THE EXTERIOR OF THE VALVE. IT IS POSSIBLE THAT DEBRIS TEMPORARILY PREVENTED MOVEMENT OF THE ADJUSTMENT MECHANISM, RESULTING IN A NON-ADJUSTABLE VALVE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE PRODUCT CAUTION THAT THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. 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 THE PT CHECKED INTO THE CLINIC PRESENTING ENDOCRANIAL HYPERTENSION. ACCORDING TO THE REPORT, THE PT WAS LEFT UNDER OBSERVATION, HOWEVER, HE CONTINUED TO PRESENT WITH VOMITING AND DROWSINESS. THE REPORT STATED THAT THEY WERE UNABLE TO PROGRAM THE STRATA VALVE. ACCORDING TO THE REPORT, THE STRATA VALVE WAS EXPLANTED AND A NEW VALVE WAS IMPLANTED. THE REPORT STATED THAT THE PT GOT MENINGITIS THREE WEEKS AFTER IMPLANTATION OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189052 STRATA 2 VALVE, SMALL JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D00042

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R