BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 622858 · Received July 27, 2005

    Report

    Report Number
    1226348-2005-00160
    Event Type
    Injury
    Date Received
    July 27, 2005
    Date of Event
    June 21, 2005
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING VALVE IMPLANTATION, THE PT DEVELOPED FLUID ACCUMULATION DISTAL TO THE VALVE AS WELL AS SYMPTOMS OF SHUNT OBSTRUCTION. THE SURGEON MADE A LARGE INCISION OVE THE VALVE AND NOTICED THAT THE SIPHONGUARD COMPONENT OF THE VALVE HAS DISLODGED. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention