Claria and Wide CRT-D MRI, serial RPB603896S, RPB603895S
제품 설명
The CLARIA MRI system is indicated for use in patients with a high risk of sudden death due to ventricular tachyarrhythmias and who suffer from heart failure with ventricular dyssynchrony. The device is designed to provide atrial, ventricular or both atrial pacing, cardioversion and defibrillation for the automatic treatment of atrial, ventricular tachyarrhythmias, or both, which may endanger the patient's life.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.
Nationwide and Western Europe: Austria Belgium Denmark Finland France Germany Italy Netherlands Poland Portugal Spain Sweden UK Switzerland Greece Malta Eastern Europe: Czech Republic Lithuania Latvia Romania Bulgaria Croatia Slovenia Slovakia Russia Serbia Middle East! Africa: South Africa Israel Iran Iraq Jordan Lebanon Suadi Arabia Turkey Latin America: Argentina Brazil Chile Colombia EI Salvador Guatamala Mexico Uruguay Venezuela Asia-Pacific: China Hong Kong Malaysia Taiwan Thailand Australia-New Zealand: Australia New Zealand and Canada
제품 설명
Photo DR, Model V-230HV || Implantable Cardioverter Defibrillator