BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE RT ANGLE

    MDR report key: 1023376 · Received April 2, 2008

    Report

    Report Number
    1226348-2008-00072
    Event Type
    Injury
    Date Received
    April 2, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS SA
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT "VALVE WOULD NOT FUNCTION APPROPRIATELY. SURGEON VERIFIED SETTING OF 40MMH2O, HOWEVER, VENTRICULAR PRESSURE EXCEEDED 180MMH2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE RT ANGLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention