BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 1924860 · Received December 9, 2010

    Report

    Report Number
    1226348-2010-00422
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    December 6, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 OF MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    REP REPORTED THAT THE DEVICE IS NOT ADJUSTING AND THE PT'S VENTRICLES REMAIN ENLARGED. AS A RESULT, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention