BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 488124 · Received October 2, 2003

    Report

    Report Number
    6000030-2003-00896
    Event Type
    Malfunction
    Date Received
    October 2, 2003
    Date of Event
    September 8, 2003
    Report Date
    September 16, 2003
    Manufacturer
    RICE CREK MANUFACTURING
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD VERY GOOD RESPONSE TO INTRATHECAL BACLOFEN FOR SEVERAL MONTHS POST IMPLANT. THEN, PATIENT REQUIRED INCREASING DOSES AND DID NOT RESPOND AS EXPECTED. PATIENT HAD UNACCEPTABLE INCREASE OF TONE. TESTS DONE INCLUDED CATHETER - FREE FLOW OF CSF AND DYE STUDY - NO ABNORMALITIES NOTED. TRIED A DRUG HOLIDAY AND PATIENT DID NOT RESPOND TO BOLUS DOSE. CATHETER AND PUMP REPLACED. ON SURGICAL EXPLORATION, CATHETER WAS FOUND TO BE VISIBLY LEAKING DISTALLY AT THE CATHETER CONNECTOR. PATIENT HAS BEEN DOING BETTER WITH NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED CATHETER LKK RICE CREK MANUFACTURING 8711 L78727

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR PUMP MODEL 862718 IMPLANT 2000, EXPLANT 2003.