BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1040069 · Received May 7, 2008

    Report

    Report Number
    1226348-2008-00117
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 6, 2008
    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
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICES WHICH HAVE INTERFERED WITH THEIR PROGRAMMING AND/OR PRESSURE CONTROL MECHANISMS. THE BIOLOGICAL DEBRIS HAS CAUSED THE RETURNED VALVES TO FAIL THE PROGRAMMING AND/OR PRESSURE TESTS AND APPEARS TO HAVE CAUSED THE DIFFICULTIES EXPERIENCED BY THE CUSTOMERS. 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 CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED, THAT WHEN THE SURGEON WAS TRYING TO REPROGRAM THE VALVE, IT WAS NOT POSSIBLE. AS A RESULT, HE HAD TO RETIRE IT AND RE-IMPLANT ANOTHER ONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention