BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HAKIM VALVE

    MDR report key: 1013858 · Received March 14, 2008

    Report

    Report Number
    1226348-2008-00056
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 23, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./ MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 INFO REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PT SUFFERED FROM HEADACHES AND VOMITED AND SHOWED WIDE VENTRICLE. AFTER INTRAOPERATIVE DISCONNECTING OF THE PERITONEAL CATHETER THERE WAS NO FLOW. AFTER DISCONNECTION OF THE VENTRICLE CATHETER THERE WAS FLOW. THEREFORE, THE SURGEONS ASSUMED THERE WAS A BLOCKAGE OF THE VALVE AND EXPLANTED THE VALVE AND REPLACE IT WITH A NEW ONE. POSTOPERATIVE THE PT WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention