BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2931735 · Received January 28, 2013

    Report

    Report Number
    1226348-2013-11577
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 3, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. CUTS/TEARS WERE ALSO OBSERVED, HOWEVER IT IS NOT POSSIBLE TO DETERMINE IF THIS OCCURRED DURING THE IMPLANT OR THE EXPLANT OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE WAS NO LONGER PROGRAMMABLE, DESPITE SEVERAL TRIALS BY DIFFERENT DOCTORS. AS A RESULT THEY DECIDED TO EX-PLANT THE VALVE AND REPLACE IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37712 HAKIIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS JXG CODMAN & SHURTLEFF, INC CNBBT7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention