BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 5510688 · Received March 18, 2016

    Report

    Report Number
    1226348-2016-10221
    Event Type
    Injury
    Date Received
    March 18, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    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 THE INVESTIGATION IT WAS NOTED THAT THE VALVE WAS VISUALLY INSPECTED IT WAS NOTED 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: A SCRATCH MARK IN THE VALVE CASING WAS NOTED. CORROSION WAS NOTED ON THE STATOR. THE CAM MAGNETS WERE CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112 WITH LOT CKDCN3, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 15TH APRIL 2009. THE ROOT CAUSE OF THE CORROSION COULD NOT BE CLEARLY DETERMINED. THE ROOT CAUSE OF THE SCRATCH MARK IS PROBABLY DUE TO THE VALVE RECEIVING SOME FORM OF IMPACT, THIS HOWEVER COULD NOT BE DETERMINED. INVESTIGATION FOR THE CORROSION ISSUE ON HAKIM VALVES IS BEING FOLLOWED WITH CAPA. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS MIXED UP WITH DEVICE FROM A SEPARATE REPORT. HERE IS THE CORRECTED INVESTIGATION REPORT FOR THE CORRECT DEVICE FROM THIS COMPLAINT: UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VALVE WAS VISUALLY INSPECTED IT WAS NOTED 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: A SCRATCH MARK IN THE VALVE CASING WAS NOTED. CORROSION WAS NOTED ON THE STATOR. THE CAM MAGNETS WERE CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112 WITH LOT CJCDHL, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 15TH APRIL 2009. THE ROOT CAUSE OF THE CORROSION COULD NOT BE CLEARLY DETERMINED. THE ROOT CAUSE OF THE SCRATCH MARK IS PROBABLY DUE TO THE VALVE RECEIVING SOME FORM OF IMPACT, THIS HOWEVER COULD NOT BE DETERMINED. INVESTIGATION FOR THE CORROSION ISSUE ON HAKIM VALVES IS BEING FOLLOWED WITH CAPA. 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

    STATOR DISLODGED, PATEINT SHOWED NO SYMPTOMS.IMPLANTATION: (B)(6) 2008.EXPLANTATION: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165814 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CJCDHL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention