BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1707490 · Received June 1, 2010

    Report

    Report Number
    1226348-2010-00174
    Event Type
    Injury
    Date Received
    June 1, 2010
    Date of Event
    April 18, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT CHILD SHOWED PRESSURE CONTROL SYMPTOMS DESPITE SEVERAL ADJUSTMENT ATTEMPTS TO PROGRAM THE VALVE TO AN OPTIMAL PRESSURE BETWEEN 60 AND 120 MMHG. IT WAS HOWEVER NOTED THAT DURING THE PROGRAMMING ATTEMPTS, THE DEVICE PROGRAMMED CORRECTLY. AS A RESULT THE DEVICE WAS EXPLANTED.

    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. NA CKPBW7

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention