BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/PRECHAMBER

    MDR report key: 910126 · Received September 11, 2007

    Report

    Report Number
    1226348-2007-00239
    Event Type
    Injury
    Date Received
    September 11, 2007
    Date of Event
    June 5, 2007
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE EVALUATION IT WAS NOTED THAT THE INVESTIGATION DID CONFIRM THE PROBLEM. THE VALVE COULD NOT REPROGRAM AND DID NOT CONTROL THE PRESSURE AS EXPECTED. THE SERIAL NUMBER OF THE VALVE WAS FOUND, THE LOT NUMBER WAS FOUND TO BE CGLCHW AND THE PRODUCT CODE WAS 82-3110. BIOLOGICAL DEBRIS WAS THE APPARENT ROOT CAUSE OF THE PRESSURE AND PROGRAMMING TEST FAILURE. THE BIOLOGICAL DEBRIS NOTED IN THE PRESSURE CONTROL MECHANISM STUCK THE CAM TO THE SPRING AND TO THE BASE PLATE. THE THIN LAYER OF BIOLOGICAL DEBRIS NOTED ON THE RUBY BALL SURFACE INTERFERED WITH A PROPER SEATING OF THE BALL ON ITS SEAT. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED IN STOCK IN NOVEMBER 2006. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE SHUNT SYSTEM DIDN'T WORK SO IT WAS NECESSARY TO MAKE A SHUNT REVISION. THE SHUNT WAS PROGRAMMED AT 90 MMH2O, HOWEVER, A TEST DURING THE OPERATION CONFIRMED THE SHUNT WAS OPENED AT 150MM H2O. THE DOCTOR BELIEVES THAT IT MUST BE A BLOCK OF THE SHUNT.

    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 CGLCHW

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention