BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 1638551 · Received March 22, 2010

    Report

    Report Number
    1226348-2010-00082
    Event Type
    Injury
    Date Received
    March 22, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    K974739
    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

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT AT 140MMH2O. DOI IS UNKNOWN. ON (B) (6) 2010, IT WAS FOUND THAT THE VENTRICLES OF THE PATIENT'S BRAIN BECAME TOO LARGE. ON (B) (6), THE DEVICE WAS REPLACED BY 82-3110 VIA V-P AT 140MMH2O.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention