BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, OSF FLD CONTROL DV

    MDR report key: 1402228 · Received June 10, 2009

    Report

    Report Number
    1226348-2009-00151
    Event Type
    Injury
    Date Received
    June 10, 2009
    Date of Event
    May 5, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE WAS IMPLANTED IN EARLY 2007. IN 2009, IT WAS FOUND THAT THE VENTRICLES OF THE PATIENT'S BRAIN HAD BECOME ENLARGED. IT WAS ALSO FOUND THAT THE SIPHON GUARD WAS BROKEN. AS A RESULT, ONLY THE SIPHON GUARD WAS REPLACED WITH ANOTHER OF THE SAME PRODUCT. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIPHONGUARD, OSF FLD CONTROL DV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC/MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention