BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL PROGRAMMABLE PUMP

    MDR report key: 524142 · Received May 4, 2004

    Report

    Report Number
    2182207-2004-00578
    Event Type
    Other
    Date Received
    May 4, 2004
    Report Date
    March 24, 2004
    Manufacturer
    NEURO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "EFFICACY OF INTRATHECAL MORPHINE IN THE TREATMENT OF BACLOFEN TOLERANCE IN A PATIENT ON INTRATHECAL BACLOFEN THERAPY (ITB) SPINAL CORD (2004) 42, 50-51." REPORTED TOLERANCE TO INTRATHECAL BACLOFEN AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PROGRAMMABLE PUMP PUMP LKK NEURO 8626-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization