BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1083498 · Received July 29, 2008

    Report

    Report Number
    1226348-2008-00192
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    June 27, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./ MEDOSA S.A.
    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

    IT HAS BEEN COMMUNICATED BY THE AFFILIATE THAT THE DEVICE IS AVAILABLE FOR EVAL. AT THIS TIME, IT IS ALSO OUR UNDERSTANDING THAT THE PT EXPIRED DUE TO REASONS UNRELATED TO THE DEVICE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE STEPPING MOTOR IN THE VALVE DETACHED FROM THE BASE PLATE. IT WAS ALSO NOTED THAT THE VENTRICLES OF THE PT'S BRAIN WERE TOO SMALL. IT WAS ALSO REPORTED THAT THE PT EXPIRED DUE TO PNEUMONITIS. IT WAS IMPLANTED IN 2008 AND REMOVED ON THE FOLLOWING MONTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention