BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2483755 · Received March 8, 2012

    Report

    Report Number
    1226348-2012-00114
    Event Type
    Injury
    Date Received
    March 8, 2012
    Date of Event
    January 17, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE RETURNED WAS ACTUALLY THAT OF PRODUCT CODE 82-3100 AND NOT THAT OF 82-3110. EXAMINATION OF THE VALVE DETERMINED THAT BIOLOGICAL DEBRIS WITHIN THE DEVICE LIKELY CAUSED THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. THIS BIOLOGICAL DEBRIS WAS DISLODGED DURING FLOW TESTING OF THE RETURNED VALVE. AFTER DISLODGING, THE VALVE PASSED THE PROGRAMMING AND PRESSURE TESTS. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT AFTER AN MRI SCAN, THE VALVE WAS NO LONGER ADJUSTABLE. AS A RESULT THE DEVICE WAS 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 AND SHURTLEFF - MEDOS CMH1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention