Defibrillator for Cardiac Resynchronization Therapy and Pacemakers CHARISMA, MOMENTUM, RESONATE, VIGILANT, AUTOGEN
Modèle / numéro de série
Description du dispositif
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.
“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.”