BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACKAGED VALVE PROGRAMMABLE UN

    MDR report key: 2210346 · Received August 9, 2011

    Report

    Report Number
    1226348-2011-00302
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 13, 2011
    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 Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT OVER DRAINAGE WAS NOT OBSERVED IN THE LABORATORY ENVIRONMENT. IT WAS HOWEVER NOTED THAT AN OCCLUSION WAS PRESENT, WHICH PREVENTED THE DEVICE TO FLOW FREELY. WHEN THE OCCLUSION WAS REMOVED AND THE DEVICE IRRIGATED AGAIN, THE FLOW WAS NORMAL. IT WAS ALSO NOTED THAT THE DEVICE FAILED THE PROGRAMMING TEST. BIOLOGICAL DEBRIS WAS FOUND THROUGHOUT THE DEVICE. THIS APPEARED TO BE THE ROOT CAUSE FOR THE DEVICE PROBLEM. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT'S FATHER REPORTED THAT HIS SON RECEIVED A SHUNT THAT OVER DRAINED. AS A RESULT, AN ANTI-SIPHONING DEVICE WAS ATTACHED. THE OVER DRAINAGE APPEARS TO HAVE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACKAGED VALVE PROGRAMMABLE UN SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CLKBCF

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention