BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE INLINE UNIT (INTEGRAL CON)

    MDR report key: 1910668 · Received November 22, 2010

    Report

    Report Number
    1226348-2010-00392
    Event Type
    Injury
    Date Received
    November 22, 2010
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE DEVICE WAS TESTED AND FAILED THE PRESSURE AND PROGRAMMING TESTS. AN OCCLUSION WAS NOTED. WHEN THE DEVICE WAS IRRIGATED THE DEVICE FLOWED AS EXPECTED. THE ROOT CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER APPEARS TO HAVE BEEN CAUSED FROM BIOLOGICAL DEBRIS SEEN THROUGHOUT THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECS 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

    AFFILIATE REPORTED THAT THE VENTRICLES OF THE PT'S BRAIN BECAME ENLARGED. ALSO, AN OCCLUSION OF THE VALVE WAS CONFIRMED BY SHUNTOGRAPHY. THE DOCTOR CHANGED THE PRESSURE, HOWEVER SINCE THE PT'S CONDITION DID NOT IMPROVE THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE INLINE UNIT (INTEGRAL CON) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA CLBC9D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention