BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 2111718 · Received May 25, 2011

    Report

    Report Number
    2021898-2011-00098
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 24, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSED SIPHON TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR REFLUX AND LEAK TESTING DUE TO A PINHOLE IN THE TOP OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE DEVICE MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVE AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PT WAS REPORTED. 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 A VALVE REVISION OCCURRED. ACCORDING TO THE REPORT, THE VALVE COULD NOT SHUNT THE CEREBROSPINAL FLUID. THE DOCTOR TRIED PUSHING ON THE RESERVOIR; HOWEVER, THE SHUNT WAS STILL NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY C58441

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R