BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 3041423 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-15071
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED AN OCCLUSION IN THE DEVICE AND FOR THE RETURNED VALVE TO FAIL THE PROGRAMMING TEST, WHICH APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. 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

    THE SALES REP REPORTED THAT THE SURGEON REMOVED A VALVE AS IT WOULD NOT PROGRAM. HE OBSERVED THAT THE VALVE APPEARED TO HAVE BEEN FLIPPED, WHICH MAY ACCOUNT FOR THE PROGRAMMING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142702 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CNLCHW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention