BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1201525 · Received October 17, 2008

    Report

    Report Number
    6000030-2008-06641
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERTONICITY AND DECREASED EFFECT DESPITE INCREASED DOSAGES OF MEDICATION. AN X-RAY SHOWED THAT THE CATHETER HAD MIGRATED FROM THE INTRATHECAL SPACE AND WAS WRAPPED BEHIND THE PUMP. THE PUMP AND CATHETER WERE REPLACED IN 2008. THE OLD PUMP HAD BEEN INFUSING 2000 MCG/ML OF LIORESAL AT AN INFUSION RATE OF 935 MCG/DAY. THE NEW PUMP WAS FILLED WITH 500 MCG/ML OF LIORESAL AND PROGRAMMED WITH AN INFUSION RATE OF 50 MCG/DAY AS THE PATIENT HAD NOT BEEN RECEIVING MEDICATION FOR AN UNSPECIFIED TIME. THE RATE WAS INCREASED TO 90 MCG/DAY. THE PATIENT WAS DOING WELL AT THE LOWER DOSE. THE HCP REPORTED THE PATIENT OUTCOME AS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention CATHETER MODEL 8711 LOT# J11153R41 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| CATHETER MODEL 8596 LOT# B004461N59 IMPLANTED| EXPLANTED