BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 1560524 · Received December 14, 2009

    Report

    Report Number
    1226348-2009-00336
    Event Type
    Injury
    Date Received
    December 14, 2009
    Date of Event
    November 9, 2009
    Report Date
    November 17, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE PRODUCT CODE WAS FOUND TO BE 82-3110 AND NOT THAT OF 82-3115 AS PREVIOUSLY REPORTED BY THE CUSTOMER. THE VALVE WAS IRRIGATED AND AN OCCLUSION WAS NOTED AT THE RUBY BALL. THE DEVICE WAS TESTED FOR PRESSURE AND PASSED THE TEST. THE DEVICE WAS THEN DISMANTLED AND VISUALLY INSPECTED UNDER MAGNIFICATION AND BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. BIOLOGICAL DEBRIS WAS THE APPARENT ROOT CAUSE OF THE DEVICE FAILURE. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECS WHEN RELEASED TO STOCK. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THERE WAS NO FLOW THROUGH THE SHUNT. AS RESULT, THE DEVICE WAS REVISED AND THE PT IS FEELING BETTER.

    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., MEDOS S.A. NA CKCBP8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention