BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/SIPHON GUARD

    MDR report key: 1002528 · Received February 26, 2008

    Report

    Report Number
    1226348-2008-00041
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 20, 2008
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN IS EXPECTING THE PRODUCT BACK FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE BROKE THREE WEEKS AFTER SURGERY. AS A RESULT, A REVISION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE VALVE IN-LINE W/SIPHON GUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2.5 YR Required Intervention