BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, SMALL, WITH BIOGLIDE

    MDR report key: 1791369 · Received August 6, 2010

    Report

    Report Number
    2021898-2010-00173
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH PROTEINACEOUS DEBRIS WAS OBSERVED ON THE INTERIOR OF THE VALVE, THE VALVE WAS PATENT. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. THE VALVE PASSED LEAK AND SIPHON TESTING, AS WELL AS ALL PERFORMANCE SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. HOWEVER, THE VALVE FAILED REFLUX TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE PRODUCT CAUTIONS THAT PARTICULATE MATTER THAT ENTERS THE SHUNT SYSTEM MAY HOLD PRESSURE/FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN OVERDRAINAGE AND REFLUX. A REVIEW OF MFG 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 THAT THERE WAS A POSSIBILITY OF VALVE OCCLUSION. THE ISSUE WAS FOUND INTRAOPERATIVE AND THE DEVICE WAS NOT IMPLANTED. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, SMALL, WITH BIOGLIDE JXG MEDTRONIC NEUROSURGERY NA C61689

    Patients

    Seq Age Sex Outcome Treatment
    1