BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 3938081 · Received July 16, 2014

    Report

    Report Number
    1226348-2014-11819
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 27, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3114, WITH LOT NUMBER CNJCV7, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 2ND OCTOBER 2012. AS PRODUCT CODE 82-3114 LOT CNJCV7 WAS NOT RETURNED FOR INVESTIGATION THE ROOT CAUSE WAS NOT DETERMINED, IF THE VALVE IS RETURNED IN THE FUTURE THE COMPLAINT WILL RE-OPENED AND THE VALVE INVESTIGATED. THE OPERATORS IN CHARGE OF THE INSPECTION AND THE MANUFACTURING OF THE PRODUCT CODE INVOLVED IN THIS COMPLAINT WERE RE-TRAINED TO APPLICABLE PROCEDURES. (B)(4) IS ONGOING TO IMPROVE THE SEGREGATION OF PYROGEN SAMPLES. BASED ON THE INVESTIGATION NO ADDITIONAL ACTION REQUIRED. TRENDS WILL BE MONITORED FOR SIMILAR COMPLAINT. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE EXPLAINED AN ERROR IN THE EVENT AND ALERT DATE. THEY EXPLAINED YES THERE IS AN ERROR. EVENT DATE IS (B)(6) 2014. ALERT DATE IS (B)(6) 2014. APOLOGIES FOR THE INCONVENIENCE CAUSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DOCTORS IMPLANTED ONE CODMAN HAKIM PROGRAMMABLE MICROVALVE TO A BABY, AS A VENTRICULOATRIAL DRAINAGE SYSTEM. THE ATRIAL CATHETER PRESENTED A BLOOD REFLUX THAT INVADED AL THE VALVE, BLOCKING IT. THE PATIENT PRESENTED A VALVE DISFUNCTION SYSTEM, SO THEY EXPLANTED THE DAMAGED VALVE AND IMPLANTED A NEW ONE (823114 AGAIN). THE SAME PROBLEM HAPPENED AGAIN, SO THEY EXPLANTED THE VALVED AND GAVE IT TO ME IN ORDER THE DETERMINE WHAT COULD HAVE BEEN THE PROBLEM. (B)(6) 2014, ADDITIONAL QUESTIONS WERE ASKED IF EITHER OF THE BLOCKAGES OCCURRED INTRA-OPERATIVELY. RESPONSE RECEIVED FROM CUSTOMER: THEY IMPLANTED THE VALVE. SOME WEEKS LATER, THE PATIENT CAME TO THE HOSPITAL WITH SOME DISEASES, SO THE DOCTORS EXAMINED HIM, AND DISCOVERED A VALVE DISFUNCTION WAS HAPPENING, DUE TO A BLOCKAGE. THEY EXPLANTED THE VALVE, AND REALISED THE BLOCKAGE WAS DUE TO A BLOOD INVASION. THE IMPLANTED A SECOND VALVE, AND THE PROBLEM HAPPENED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415032 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN & SHURTLEFF CNJCV7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention