“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
Patients with alterations in the generation and / or conduction of the cardiac electrical impulse. Pulse generators or pacemakers with magnetic resonance imaging (MRI) are conditionally safe in the MRI environment (magnetic resonance imaging) if a complete MRI system is used and in accordance with the instructions for use
Indicated for patients with symptomatic congestive heart failure, including left ventricular dysfunction and a wide range of QRS, as well as one or more of the following conditions: - paroxysmal or permanent symptomatic second and third degree AV block. -blocking of bilateral symptomatic branch. - dysfunction of the paroxysmal or transient sinus-synomatic node with or without associated AV conduction disorder (eg sinus bradycardia, sinus arrest, neuroauricular block (SA) - bradycardia - tachycardia syndrome, to prevent symptomatic bradycardia or certain forms of symptomatic tachyarrhythmias.
These defibrillators for cardiac resynchronization therapy (CRT-D) are indicated for patients who are at risk of suffering a cardiac death due to ventricular arrhythmias and heart failure, including ischemic heart failure (NYHA class I), with ventricular dyssynchrony. CRT-D are also indicated to provide ventricular tachycardia and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias.