MRI (magnetic resonance imaging)uses a large, circular magnet and radio waves to produce clear computer images of the body. When assessing potential risk for a patient if their devicetransitions to safety mode, consider patient-specific factors (which may vary over time), including underlying health issues, pacemaker dependence, or problems with pacing. Report adverse events experienced with the INGENIO family of pacemakers or CRT-Ps to Boston Scientific or the FDAs MedWatch Adverse Event Reporting program. Boston Scientific INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are devices used with patients who have low heart rates, and patients with moderate to severe heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. 00802526480713 GUDID Code | E140 Model | BOSTON SCIENTIFIC CORPORATION Included in the case studies are examples from pacemakers, ICDs and CRT devices, illustrating interpretation and management of a variety of device behaviors, some with abnormal function that requires diagnosis and management approach, and others that display appropriate behavior of a specific device algorithm that may be confusing for the CIED 880 MRI Compatible Anaesthesia Machine Mechanical ventilation Pneupac ACT (computed tomography)scan generates a cross-sectional view ofyourbody through a series of X-ray images. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Number of medical devices in the base package. Rx only. MARLBOROUGH, Mass., April 20, 2016 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has received CE Mark approval for the new EMBLEM MRI Subcutaneous Implantable. How does the EMBLEM S-ICD differ from transvenous ICDs? Find product information, guides and more for patients living with a CRT device. Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model MRI Safe in Patients With Subcutaneous Defibrillators Kate Johnson March 11, 2014 VIENNA Patients implanted with a subcutaneous implantable cardioverter defibrillator ( S-ICD System,. Dont Let Heart Disease Stop You, Why You May Not Realize You Need a Pacemaker, Pacemakers and Defibrillators Save Lives In Different Ways. See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Using household appliances and tools (EMI safety guide), EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. It includes the manufacturer, model name and model number, a website and a phone number to call with questions. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Is MRI Safe for Patients with Cardiac Devices? If you would like to request a new manual, call Boston Scientific Patient Services at (866) 484-3268. Boston Scientific Increases Longevity Projections for Its U.S Is a Hidden Pacemaker Infection Making You Sick? If you have an implanted device such as apacemaker, heart valve, stent orimplantable cardioverter defibrillator (ICD), youre probably aware that it canset off the metal detector at the airport. Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 00802526587788 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 106295384 * Terms of Use Device Description: Implantable Cardioverter Defibrillator VR CLOSE Device Characteristics Device Record Status Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of this system. GMDN Names and Definitions: Copyright GMDN Agency 2015. FIND INSTRUCTIONS FOR USE MR-Conditional Device Information The ENERGEN ICD, with the 4 SITE DF4 connector system, is designed to streamline the implant procedure and make the thinnest, long lasting high energy devices in the world even smaller. The version or model found on the device label or accompanying packaging used to identify a category or design of a device. Know how your device works with other medical procedures. Apr 20, 2016, 07:00 ET. AUTOGEN (D044, D046, D174, D175, D176, D177), DYNAGEN DAI (D020, D021, D022, D023, D150, D151, D152, D153), INOGEN DAI (D010, D011, D012, D013, D140, D141, D142, D143), ORIGEN DAI (D000, D002, D003, D050, D051, D052, D053), working group of pacing and electrophysiology of the FrenchSocietyofCardiology. The device may or may not still be available for purchase in the marketplace. Return explanted devices to Boston Scientific. Accent MRI and Accent ST MRI Cardiac Pacemaker Systems, Models PM1224,PM2224, PM1226, PM2226, PM1124 PM2124, St. Jude Medical, Inc., www.sjm.com/mriready [8] The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Advertising on our site helps support our mission. Saint Paul MN 55112-5700. Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Visit: IMRSER.org MRI Safety Videos Boston Scientific EMBLEM S-ICD System Due to Risk of Short-Circuit An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. Most implanted devices available today can go through a CT scan or an MRI scanner. Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient. Do you have information I can share with my family about my implanted heart rhythm device? Bioz Stars score: 86/100, based on 1 . Only applicable to devices not subject to the requirements under 21 CFR 801.437. Boston Scientific Icd | Boston Scientific | Bioz INGEVITYTM+:7840, 7841, 7842 If the. Here, diagnostic radiologistScott Flamm, MD, reviews what you need to knowabout getting medical scans when you have an implanted cardiac device. Boston Scientific does not recommend preventive replacement for affected devices. Certain Boston Scientific pacemakers and defibrillators come with an automatic, in-home monitoring system called LATITUDE. All rights reserved. Additional undefined device size not represented in the GUDID Size Type LOV. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog.