BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/SIPHON GUARD

    MDR report key: 1051588 · Received May 21, 2008

    Report

    Report Number
    1226348-2008-00136
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 2, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. 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 THAT COULD EFFECT PRESSURE CONTROL. 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

    CUSTOMER REPORTS THAT: "AFTER JUST 2 YEARS, THE ORIGINALLY IMPLANTED CHPV BEGAN TO FAIL. THE DOCTOR TRIED TO READJUST VALVE AND WAS ABLE TO DO SO (CONFIRMED WITH X-RAY), BUT PT REMAINED SYMPTOMATIC AND MAINTAINED ENLARGING VENTRICLES. AS A RESULT, THE SURGEON DECIDED TO REPLACE THE MALFUNCTIONING CHPV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention