BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1936116 · Received December 13, 2010

    Report

    Report Number
    1226348-2010-00428
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 25, 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 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 SHUNT HAD NO EFFECT ON HYDROCEPHALIC EMPTYING AND NO EFFECT ON VENTRICULAR SIZE. CONDUCTANCE TEST IN (B)(6) 2010 REVEALS PATHOLOGIC TESTING PRESSURE AND CONDUCTANCE (0.9 HPA;4.9). SHUNT WAS REVISED: FREE FLOW OF CSF FROM VENTRICULAR CATHETER, FREE FLOW IN THE DISTAL CATHETER. PRESSURE MEASUREMENT IN THE SHUNT VALUE SHOWS THAT IT OPENS ON A HIGHER PRESSURE THEN THE ADJUSTED PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN & SHURTLEFF, INC, MEDOS S.A. NA CJMBM2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention