BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 1051603 · Received May 21, 2008

    Report

    Report Number
    1226348-2008-00130
    Event Type
    Injury
    Date Received
    May 21, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVAL. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW-UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE WAS IMPLANTED IN A CHILD IN EARLY 2007. IT WAS REPLACED IN 2008. IT SEEMS THAT IT WAS BLOCKED WITH DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention