BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 720312 · Received May 24, 2006

    Report

    Report Number
    6000030-2006-00851
    Event Type
    Other
    Date Received
    May 24, 2006
    Date of Event
    September 30, 2005
    Report Date
    May 18, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING INCREASED SPASMS INSPITE OF DOSE INCREASS TO OVER 1300MCG/DAY. A DYE STUDY DONE ON 03/04/2003 DID NOT REVEAL ANY PROBLEM WITH THE PUMP OR CATHETER. A CATHETER REVISION WAS DONE ON 2003 AND THE DOSE WAS STARTED AT 150MCG/DAY. SINCE THEN, THE DOSE WAS INCREASED SEVERAL TIMES TO 1340MCG/DAY WITH NO RELIEF. THE PATIENT WAS THEN SENT TO ANOTHER PHYSICIAN FOR PHENOL INJECTIONS IN THE LEGS. THE INFUSION MODE WAS CHANGTED TO PERIODIC BOLUS. THE HCP REPORTS THE PATIENT'S SPASMS ARE STILL NOT UNDER CONTROL.

    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 56 YR Hospitalization| R