BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER

    MDR report key: 3841376 · Received May 30, 2014

    Report

    Report Number
    1226348-2014-11689
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DID VALVE CONFIRMED A PROBLEM. THE LOT NUMBER 1119890, SERIAL NUMBER WAS (B)(4), PRODUCT CODE 82-3101. VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: IT WAS NOTED THAT THE VALVE CASING WAS CRACKED AND THERE WAS A BUMP MARK IN THE VALVE CASING, THIS IS DUE TO THE VALVE RECEIVING A HARD KNOCK. IT WAS ALSO NOTED THAT THE CAM MECHANISM WAS DAMAGED, THIS IS ALSO DUE TO THE VALVE RECEIVING A HARD KNOCK. THE LOT HISTORY RECORD WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK ON THE (B)(6) 2003. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT AT 120MMH2O TO THE PATIENT IN 2004. ON (B)(6) 2014, MRI WAS CONDUCTED AND THE SETTING PRESSURE WAS CONFIRMED AS 120MMH2O. AFTER MRI, THE SURGEON TRIED TO CHANGE THE SETTING PRESSURE BUT COULDN'T. THEREFORE, ON (B)(6) 2014, THE REVISION SURGERY WAS CONDUCTED AND THE DEVICE WAS REPLACED TO THE PRODUCT MANUFACTURED BY MEDTRONIC(STRATA) WHOSE SETTING PRESSURE IS NOT REPORTED. THE SETTING PRESSURE OF THE REMOVED VALVE WAS 120MMH2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319212 HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 1119890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention