“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
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.