BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 721775 · Received June 1, 2006

    Report

    Report Number
    1226348-2006-00131
    Event Type
    Other
    Date Received
    June 1, 2006
    Date of Event
    May 5, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC./ MEDOS S.A.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT A SHUNT IN THE PATIENTS ABDOMEN IN 2006. IT DID NOT WORK THEREFORE THE SURGEON DECIDED TO IMPLANT THE VALVE IN THE PLURA OF THE PATIENT'S CHEST. THE PT DID WELL UNTIL WEDNESDAY. PT ASPIRATED AND CODED. MEDICAL PROFESSIONALS INDICATED THAT THE DEVICE DID NOT CONTRIBUTE TO THE PTS DEATH. REP CONFIRMED THAT AN AUTOPSY WAS NOT PERFORMED, THEREFORE WE WILL NOT BE GETTING THE VALVE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other