BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 3450402 · Received November 5, 2013

    Report

    Report Number
    1226348-2013-32545
    Event Type
    Injury
    Date Received
    November 5, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC MEDOS
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT PERTAINS TO (B)(4). REPORTING DECISION IS BEING CHANGED FROM MALFUNCTION TO SERIOUS INJURY REP REPORTED VIA EMAIL WITH A PHONE CALL FOLLOW UP INDICATING THAT THE ACCOUNT IMPLANTED A CERTAS AND THE RESIDENTS ARE HAVING DIFFICULTY READING/PROGRAMMING THE VALVE. THEY ARE EXPERIENCING DIFFICULTY IN CONFIRMING THE X-RAY POSITION AND THE PROGRAMMING TOOL IS NOT WORKING CORRECTLY. THE DEVICE IS SITLL IMPLANTED. MORE INFORMATION IS EXPECTED. ADDITIONAL INFORMATION VIA A PHONE CONVERSATION EXPLAINED THAT THE EVENT OCCURRED POST-OP. THE SURGEON WANTED TO X-RAY THE PATIENT TO MAKE SURE THE SETTING HAD NOT MOVED FROM THE INITIAL SETTING OF 7. HOSPITAL COULD NOT DETERMINE ACTUAL SETTING.

    Description of Event or Problem · 1

    THIS COMPLAINT PERTAINS TO (B)(4). REPORTING DECISION IS BEING CHANGED FROM MALFUNCTION TO SERIOUS INJURY.REP REPORTED VIA EMAIL WITH A PHONE CALL FOLLOW UP INDICATING THAT THE ACCOUNT IMPLANTED A CERTAS AND THE RESIDENTS ARE HAVING DIFFICULTY READING/PROGRAMMING THE VALVE. THEY ARE EXPERIENCING DIFFICULTY IN CONFIRMING THE X-RAY POSITION AND THE PROGRAMMING TOOL IS NOT WORKING CORRECTLY. THE DEVICE IS SITLL IMPLANTED. MORE INFORMATION IS EXPECTED.ADDITIONAL INFORMATION VIA A PHONE CONVERSATION EXPLAINED THAT THE EVENT OCCURRED POST-OP. THE SURGEON WANTED TO X-RAY THE PATIENT TO MAKE SURE THE SETTING HAD NOT MOVED FROM THE INITIAL SETTING OF 7. HOSPITAL COULD NOT DETERMINE ACTUAL SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568729 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN & SHURTLEFF, INC MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention