BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CERTAS SIPHONGUARD

    MDR report key: 6894012 · Received September 26, 2017

    Report

    Report Number
    6894012
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    June 20, 2017
    Report Date
    September 19, 2017
    Manufacturer
    MEDOS INTERNATIONAL SÀRL/ DEPUY INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RETURNED TO THE OR FOR EVALUATION OF A SHUNT FAILURE FOLLOWING LAPAROSCOPIC SHUNT REVISION. THE CODMAN CERTAS VALVE WAS EXPLANTED AND REPLACED DUE TO A KINK IN TH TUBING FROM THE DISTAL TAKEOFF FROM THE VALVE. THERE WAS NO HARM TO THE PATIENT . THE SHUNT VALVE WAS RETURNED TO CODMAN FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674001 CODMAN CERTAS SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDOS INTERNATIONAL SÀRL/ DEPUY INC. 82-8804PL 130601

    Patients

    Seq Age Sex Outcome Treatment
    1