BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 2241949 · Received September 9, 2011

    Report

    Report Number
    1226348-2011-00341
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 2, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED AND 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

    AFFILIATE REPORTED THAT THE DEVICE DID NOT FLOW WHILE IMPLANTED. AS A RESULT THE DEVICE WAS REMOVED AND IT WAS FOUND TO FLOW FREELY FROM THE VENTRICULAR CATHETER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1