BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3132988 · Received May 29, 2013

    Report

    Report Number
    1226348-2013-17720
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 8, 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

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT UPON RECEIPT, THE POSITION OF THE CAM WAS NOT VISIBLE DUE TO A THICK LAYER OF A WHITE SUBSTANCE COVERING THE VALVE CASING. IT WAS ALSO NOTED THAT THE VALVE MECHANISM COULD NOT BE SEEN AND THE VALVE CASING WAS NOT SEATED PROPERLY. THE DEVICE WAS TESTED, ALTHOUGH NO OCCLUSIONS WERE FOUND THE DEVICE COULD NOT BE TESTED FOR PROGRAMMING AND PRESSURE SINCE THE CAM MECHANISM WAS NOT VISIBLE. BIOLOGICAL DEBRIS WAS SEEN THROUGHOUT THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED 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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE MECHANISM BLOCKED WHEN THEY TRIED TO INCREASE THE LEVEL TO 200 DUE TO SUBDURAL HEMATOMAS. THERE WERE 10 ATTEMPTS TO READJUST THE VALVE PRIOR TO SURGERY. THE X-RAYS SHOWED SAME LEVEL AFTER EACH ATTEMPT. AS A RESULT, THE VALVE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236938 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 768346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention