BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 1695436 · Received May 19, 2010

    Report

    Report Number
    1226348-2010-00162
    Event Type
    Injury
    Date Received
    May 19, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. IN ADDITION, AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL, WHICH SUPPORTS THE CUSTOMER'S COMPLAINT. ALSO, THE BIOLOGICAL DEBRIS CAUSE THE RETURNED VALVE TO FAIL THE PROGRAMMING TEST. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATION REQUIREMENTS 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 THE PT'S VENTRICLES BECAME ENLARGED AND AS A RESULT, AN IMAGE WAS TAKEN THAT FOUND THAT THE DEVICE DID NOT FLOW. THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CJHB1N

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention