BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA VALVE SMALL (CLINICAL)

    MDR report key: 2133441 · Received June 15, 2011

    Report

    Report Number
    2021898-2011-00126
    Event Type
    Injury
    Date Received
    June 15, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K012052
    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 IDENTIFIED AS A FIRST GENERATION STRATA I VALVE, SMALL. THE DEVICE WAS RETURNED AT A PERFORMANCE LEVEL SETTING BETWEEN 2.5 AND 0.5 AND COULD NOT BE ADJUSTED TO ANY OTHER PERFORMANCE LEVELS. THE FIRST GENERATION STRATA I VALVES WERE ONLY USED FOR THE US CLINICAL TRIAL BETWEEN 2000-2001. THE FIRST GENERATION STRATA I VALVES HAD A STOP TAB TO PREVENT ADJUSTMENT DIRECTLY FROM 2.5 TO 0.5. DURING MRI EXPOSURE, THERE WAS A SMALL POTENTIAL FOR THE ROTOR TO JAM UNDERNEATH THE STOP TAB, AND THEN CAUSING THE VALVE PRESSURE SETTING TO BE STUCK (NOT ADJUSTING) BETWEEN 2.5 AND 0.5. DUE TO THIS REASON, THE STRATA I VALVES WERE RE-DESIGNED WITHOUT THIS STOP TAB MECHANISM PRIOR TO COMMERCIAL RELEASE. THE RETURNED 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 TOP OF THE DELTA CHAMBER AND A TEAR AT THE BASE OF THE VALVE. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. 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. 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 SETTING OF A CLINICAL TRIAL STRATA VALVE WAS STUCK BETWEEN PERFORMANCE LEVEL 2.5 AND 0.5. ACCORDING TO THE REPORT, THE PATIENT WAS HAVING HEADACHES AND THE PHYSICIAN DECIDED TO EXPLANT THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA VALVE SMALL (CLINICAL) JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY W0287

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R