BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNT CENTRAL NERVOUS SYSTEM AND COMPS

    MDR report key: 3760245 · Received April 19, 2014

    Report

    Report Number
    1226348-2014-11399
    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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THAT: "A CODMAN VALVE HAD NO FLOW AND HAD TO BE REVISED WITH ANOTHER CODMAN VALVE. BOTH VENTRICULAR AND DISTAL CATHETERS WERE FLOWING PROPERLY. PATIENT WAS OKAY AFTER RECEIVING THE SECOND VALVE." CUSTOMER REQUESTED A WARRANTY REPLACEMENT. CUSTOMER IS NOT CERTAIN IF THE EXPLANTED VALVE P/N 82-3164 IS FROM LOT # CMJB8W OR CMLCLN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239125 SHUNT CENTRAL NERVOUS SYSTEM AND COMPS JXG CMJB8W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention