BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT CENTRAL NERVOUS SYSTEM AND COMPS

    MDR report key: 3760202 · Received April 19, 2014

    Report

    Report Number
    1226348-2014-11397
    Event Type
    Injury
    Date Received
    April 19, 2014
    Date of Event
    March 23, 2012
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE AFFILIATE REPORTED THAT: "IT WAS REPORTED THAT THE VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2011. THE PATIENT BECAME SYMPTOMATIC RECENTLY AND THE VALVE WAS EXPLANTED AND REPLACED. SURGEON IS CONCERNED THE VALVE MAY BE BLOCKED OR MALFUNCTIONING. ADDITIONAL INFORMATION IS BEING REQUESTED AND UPDATE WILL BE PROVIDED ONCE THE INFORMATION HAS BEEN RECEIVED. DEVICE WILL BE FORWARDED ON RECEIPT". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239104 SHUNT CENTRAL NERVOUS SYSTEM AND COMPS JXG NX6319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention