BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1051579 · Received May 21, 2008

    Report

    Report Number
    1226348-2008-00133
    Event Type
    Injury
    Date Received
    May 21, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, VISUAL EXAMINATIONS OF THE RETURNED VALVES HAVE FOUND CUTS OR TEARS IN THE CATHETER CAUSED BY CONTACT WITH SHARP INSTRUMENTS DURING A SURGICAL PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. 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 CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT BREAKAGE OF CATHETER WAS NOTED, AND THEREFORE NEEDED TO BE REPLACED. IT WAS IMPLANTED IN 2008 AND REPLACED IN THREE MONTHS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention