BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 2933611 · Received January 29, 2013

    Report

    Report Number
    1226348-2013-11631
    Event Type
    Injury
    Date Received
    January 29, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    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 THE INVESTIGATION, IT WAS NOTED THAT A TEAR IN THE CATHETER WAS FOUND. IT IS NOT POSSIBLE TO DETERMINE IF THE TEAR OCCURRED DURING THE IMPLANT OR EXPLANT OF THE DEVICE. IT WAS ALSO NOTED THAT THE DEVICE FAILED THE PROGRAMMING TEST AS THE CAM MECHANISM ONLY MOVED SLIGHTLY. FURTHER INVESTIGATION REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS. DEBRIS WAS SEEN THROUGHOUT THE DEVICE. THE CAM MECHANISM WAS ALSO CHECKED FOR MAGNETISM; WITH A MAGNETIC VIEWER, THIS IS PLACED ON THE CAM MECHANISM UNDER THE MICROSCOPE, A LOSS OF MAGNETISM WAS NOTED. THE POLARITY OF THE MAGNETS IS NOT REGULAR. THIS COULD BE DUE TO THE MRI, IT WAS NOT NOTED IN THE COMPLAINT DESCRIPTION WHAT STATIC MAGNETIC FIELD USED DURING MRI. AS NOTED IN THE INSTRUCTIONS FOR USE, MRI CAN BE PERFORMED AT ANY TIME AFTER IMPLANTATION USE AN MR SYSTEM WITH A STATIC MAGNETIC FIELD OF 3 T OR LESS; USE AN MR SYSTEM WITH A SPATIAL GRADIENT OF 720 GAUSS/CM OR LESS. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS PRIOR TO DISTRIBUTION. 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

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

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED - IT WAS NOTED THAT THE VENTRICLES OF THE PATIENT'S BRAIN BECAME SMALLER AND THE PATIENT HAD A HEADACHE. THE PRESSURE OF THE DEVICE WAS CHANGED TO A HIGHER SETTING. AFTER THE PATIENT'S MRI SCAN, THE DEVICE COULD NOT REPROGRAM. THE PRESSURE COULD BE CHANGED JUST BETWEEN 30-50MMH2O. NEODYMIUM CHANGED THE PRESSURE TO 120MMH2O THOUGH IT WAS NOT THE EXPECTED PRESSURE SETTING. THE VALVE WAS REPLACED BY NS9009 AT 120MMH2O DUE TO SUSPECTED BREAKAGE OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39825 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention