BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1045909 · Received May 14, 2008

    Report

    Report Number
    2182207-2008-02562
    Event Type
    Injury
    Date Received
    May 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: MOTTA F, STIGNANI C, ANTONELLO CE. EFFECT OF INTRATHECAL BACLOFEN ON DYSTONIA IN CHILDREN WITH CEREBRAL PALSY AND THE USE OF FUNCTIONAL SCALES. J PEDIATR ORTHOP 2008;28(2):213-217. THE AIM OF THE PRESENT STUDY WAS TO EVALUATE DYSTONIA TREATED WITH ITB IN CHILDREN WITH CP. NINETEEN PATIENTS WITH A MEAN AGE AT IMPLANT OF 8.49 YEARS WERE FOLLOWED FOR 12 MONTHS. THE RESULTS ALSO REVEALED A REDUCTION IN DYSTONIAS, AN IMPROVEMENT IN POSTURE, AND AN EASING OF THE TASK OF THE CAREGIVERS IN MANAGING THE PATIENT AS A RESULT OF TREATMENT WITH ITB. REPORTABLE EVENT: ONE COMPLICATION RELATED TO CATHETER OCCURRED AND IT WAS SOLVED BY CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE INFUSION PUMP MODEL UNK N=1| PROGRAMMER MODEL UNK N=1