BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1699465 · Received May 25, 2010

    Report

    Report Number
    1226348-2010-00164
    Event Type
    Injury
    Date Received
    May 25, 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

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT, TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT'S VENTRICLES BECAME ENLARGED AND AS A RESULT, THE SURGEON ATTEMPTED TO CHANGE THE PRESSURE. IT WAS THEN DISCOVERED IN AN X-RAY THAT THE STEPPING MOTOR AND THE WHITE MARKER IN THE INLET VALVE WAS DETACHED FROM THE BASE PLATE. THE DEVICE IS INTENDED TO BE REVISED.

    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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention