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Any incident with potential deleterious consequences occurring while treating a patient with a medical device concerned medical device vigilance.In Europe, as well as in other part of the world, directives have been established to set up in each country a coordinated system of device vigilance at national and local levels.Due to their structural complexity and their recent implementation of new technology, active implantable devices such as pacemaker, defibrillator and leads are frequently under the scope of vigilance organisation.