BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1081346 · Received July 24, 2008

    Report

    Report Number
    6000030-2008-04294
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BEEN EXPERIENCING A LOSS OF THERAPEUTIC EFFECT, INCREASED BASELINE SPASTICITY, DIFFICULTY WALKING, BURNING SENSATION, MOTOR WEAKNESS, PRURITUS, MUSCLE RIGIDITY, FATIGUE, HEADACHES, DIZZINESS, AN ALLERGIC REACTION, AND TINGLING. THE SYMPTOMS HAD BEEN GOING ON "FOR AWHILE NOW." THE PATIENT HAD EXPERIENCED THE SAME SYMPTOMS BEFORE WHEN A CATHETER LEAK WAS REVISED. THE PT WAS AT HOME AND HER STATUS WAS REPORTED AS "UNDETERMINED". IT WAS INDICATED THAT DIAGNOSTIC STUDIES HAD BEEN PERFORMED BUT THE DATES OF TESTING, TYPES, AND RESULTS OF TESTING WERE NOT REPORTED. THE REPORTER WAS NOT SURE IF THE BACLOFEN IN THE PUMP WAS LIORESAL BRAND OR COMPOUNDED. THE CONCENTRATION AND DAILY DOSE BEING DELIVERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8711| IMPLANTED| PROGRAMMER: MODEL PROGRAMMER