BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 2881853 · Received December 20, 2012

    Report

    Report Number
    1226348-2012-00626
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 AND PRESSURE 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

    AFFILIATE REPORTED THAT 2009 IS THE FIRST IMPLANT OF THIS VALVE. AFTER 3 YEARS ((B)(6) 2012), WHEN THE SURGEON TRIED TO PROGRAM THE VALVE WITH THE HAKIM VALVE PROGRAMMER, CODE 823190, THE PRESSURE OF THE VALVE DID NOT CHANGE. THE PRESSURE WAS SET TO 200 MMH20 AND IN SPITE OF SEVERAL ATTEMPTS, THE PRESSURE STAYED TO 200 MMH20. AN X-RAY WAS TAKEN TO CHECK IF ANY CHANGES WERE SET, BUT IT CONFIRMED THAT THE PRESSURE STAYED 200 MMH20. AS A RESULT THE VALVE WAS REMOVED FROM PATIENT AND REPLACED WITH A NEW ONE. NO ADDITIONAL INFORMATION ON THE PATIENTS CONDITION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN AND SHURTLEFF - MEDOS CHBB37

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention