BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3833671 · Received May 27, 2014

    Report

    Report Number
    1226348-2014-11674
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS VISUALLY INSPECTED AND A NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED, NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING AND PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED AND PASSED THE TEST. THE VALVE WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WERE NOTED. THE VALVE WAS DRIED AND LEAK TESTED. ONLY LEAKED FROM THE NEEDLE HOLE, NO OTHER LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED AND PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT AT 120 MMH2O TO THE PATIENT WITH SAH WHO IS (B)(6) FEMALE ON (B)(6) 2014. SINCE THE SETTING PRESSURE COULD NOT BE CHANGED AT SOME POINT IN TIME AFTER IMPLANTATION, THE REVISION SURGERY OF THE VALVE WAS CONDUCTED ON (B)(6) 2014. THE SETTING PRESSURE OF THE REMOVED VALVE WAS UNKNOWN. THE KIND AND THE SETTING PRESSURE OF THE REPLACED VALVE ARE NOT INFORMED. THE SURGEON SUSPECTED THAT THE INCIDENT WAS DUE TO DEBRIS INSIDE THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310463 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPLBHN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention