BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1961099 · Received January 12, 2011

    Report

    Report Number
    2021898-2011-00012
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS PATENT, PASSED SIPHON TESTING AND MET THE SPECIFICATION FOR PREIMPLANTATION TESTING. IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR IN THE TOP OF THE DELTA CHAMBER. THIS DAMAGE PRECLUDED REFLUX TESTING. IT IS UNK 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. 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. THE DEVICE DID NOT MEET ALL ESTABLISHED SPECIFICATIONS FOR PRESSURE FLOW TESTING. PROTEINACEOUS DEBRIS WAS FOUND IN THE INTERIOR OF THE 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. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR LOT C57271 AND A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE DID NOT WORK AND STARTED TO LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C57271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R