BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 512010 · Received February 17, 2004

    Report

    Report Number
    6000030-2004-00181
    Event Type
    Death
    Date Received
    February 17, 2004
    Date of Event
    December 28, 2003
    Report Date
    January 19, 2004
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PT DIED IN 2004 AT HOME. HCP REVIEWED THE PROGRAMMING STRIP FROM THE LAST REFILL IN 12/2003 AND EVERYTHING WAS DONE CORRECTLY; NO CHANGES WERE DONE ON THE DOSE OR CONCENTRATION. THE CORONER COULD NOT FIND AN ACUTE CAUSE OF DEATH. PRELIMINARILY SHE IS STATING THE CAUSE OF DEATH IS DUE TO THE PT'S SEIZURE DISORDER. THERE WAS NO BACLOFEN FOUND IN THE TOXICOLOGY REPORT. MORE LAB WORK WILL BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death CATHETER MODEL 8709 LOT# L55917 IMPLANTED: 1998| EXPLANTED: UNK.