BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3041417 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-15056
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 5, 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, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS VISUALLY INSPECTED, THE STATOR WAS DISLODGED AND A SMALL TEAR IN THE SILICONE HOUSING WAS FOUND. IT MIGHT BE POSSIBLE THAT THE DEVICE CAME IN CONTACT WITH A SHARP OR POINTED OBJECT. THIS HOW COULD NOT BE DETERMINED. SINCE THE STATOR WAS DISLODGED THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. UPON FURTHER EXAMINATION A CRACK WAS FOUND IN THE VALVE CASING, AND THE CAM MECHANISM WAS DAMAGED. IT MIGHT BE POSSIBLE THAT THE VALVE RECEIVED SOME FORM OF IMPACT CAUSING THE CRACKED CONDITION OF THE DEVICE. NO PERFORMANCE TESTING COULD BE CONDUCTED SINCE THE DEVICE WAS RECEIVED DAMAGED. FURTHER TO THE CUSTOMER COMPLAINT IT IS NOT KNOWN HOW OR WHY THE DEVICE CAUSED HEMORRHAGING WHILE REMOVING THE CATHETER AS THIS IS AN UNUSUAL ISSUE. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE 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 AFFILIATE REPORTED THAT AFTER THE IMPLANTATION OF THE DEVICE, A SETTING CHANGE WAS NOT POSSIBLE. THE CATHETER BECAME IN-GROWN IN THE VENTRICLE PARENCHYMA. A HEMORRHAGE OCCURRED WHEN THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142700 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CKFBC2

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention