BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA UNITIZED SHUNT, SMALL, PERFORMANCE LEVEL 1.5

    MDR report key: 2020529 · Received February 10, 2011

    Report

    Report Number
    2021898-2011-00027
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT AND PASSED SIPHON, REFLUX AND LEAK TESTING. THEREFORE, THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. THE VALVE MET REQUIREMENTS FOR PRESSURE-FLOW TESTING AT 20.4 ML/HR AT -50 CM, HOWEVER, IT DID NOT MEET SPECIFICATIONS FOR ALL OTHER PRESSURE-FLOW AND PREIMPLANTATION TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PATIENT REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ONCE THE SHUNT HAD BEEN PLACED, IT WOULD NOT FLOW DISTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA UNITIZED SHUNT, SMALL, PERFORMANCE LEVEL 1.5 JXG MEDTRONIC NEUROSURGERY NA C72933

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK