BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 1011226 · Received March 11, 2008

    Report

    Report Number
    1226348-2008-00048
    Event Type
    Death
    Date Received
    March 11, 2008
    Date of Event
    December 25, 2007
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS RECEIVED THE DEVICE FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT SHOWED SYMPTOMS OF ENDOCRANIAL HYPERTENSION DUE TO HYDROCEPHALUS. A CT-SCAN WAS PERFORMED AND IT APPEARS THAT THERE WAS A VALVE OBSTRUCTION. THE VALVE WAS EXPLANTED, AND WAS BENT AND BROKEN. THE PATIENT LATER DIED DUE TO FURTHER COMPLICATIONS. THE DOCTOR INDICATED THAT THE PATIENT WAS DETERIORATED AND HIS LIFE EXPECTANCY WAS LIMITED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death