BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.5

    MDR report key: 3032210 · Received March 29, 2013

    Report

    Report Number
    2021898-2013-00109
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND MET THE REQUIREMENTS FOR LEAK TESTING. HOWEVER, THE DEVICE DID NOT MEET THE SPECIFICATIONS FOR SIPHON, REFLUX, PREIMPLANTATION, AND PRESSURE-FLOW TESTING DUE TO THE PRESENCE OF BOTH CRYSTALLINE AND PROTEINACEOUS DEBRIS WITHIN ITS INTERIOR. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND/OR SIPHONING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE ALSO CAUTION THAT SHUNT OBSTRUCTION MAY OCCUR IN ANY OF THE COMPONENTS OF THE SHUNT SYSTEM. THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS. A REVIEW OF THE MANUFACTURING 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 TO MEDTRONIC NEUROSURGERY THAT WHILE PERFORMING A SHUNT REVISION SURGERY, THE PHYSICIAN NOTICED THAT THE IMPLANTED VALVE WAS FULL OF BLOOD AND NOT DRAINING. ACCORDING TO THE REPORT, THE PHYSICIAN FLUSHED THE VALVE, AND THEN PERFORMED MONOMETER TESTING OF THE DEVICE WHICH SHOWED IT WAS NOT WORKING CORRECTLY. REPORTEDLY, THE PHYSICIAN REPLACED THE VALVE BEFORE COMPLETING THE REVISION PROCEDURE. ACCORDING TO THE REPORT, THE PT WAS NOT INJURED AND WAS SAID TO BE "DOING WELL" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130712 DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D31020

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization