Commercial Distribution Status: In Commercial Distribution. The company said the new warranty program is the longest available in the industry and provides physicians . Data From More Than 100,000 Boston Scientific Implantable Indicates the date the DI Record is published and available via Public Search. The use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Use of these devices may cause serious injuries or death. For more information, please visit: www.bostonscientific.com . Policy. Copyright 2007-2023 HIPAASPACE. In regard to an implanted ICD, the risks include but are not limited to inappropriate shock, lead moves out of place, loss of stimulation capability, allergic reaction, fluid underneath the skin, and infection. Find products, medical specialty information, and education opportunities. 3/4" Socket Wrench . Designed to further enhance patient comfort, when used in conjunction with the ENERGEN ICD device systems, the RELIANCE lead with 4 SITE makes the thinnest high energy device system in the world even smaller. Once the wires are in place, they are attached to the heart wall. Devices that May Interfere with ICDs and Pacemakers *Also, see sections on Cardiac Monitors, such as the Reveal and Confirm Products Cardiac Pacemakers and Implantable Cardioverter Defibrillators Cardiac pacemakers and implantable cardioverter defibri, Abbott and St. Jude Medical, Cardiac Pacemaker List of MR Conditional Versions Abbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Conditional at 1.5 T and others are, Abbott and St. Jude Medical, Cardiac PacemakerList of MR Conditional VersionsAbbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Conditional at 1.5 T and others are MR, Abbott and St. Jude Medical, Implantable Cardioverter Defibrillator (ICD) List of MR Conditional Versions Abbott and St. Jude Medical, Inc., www.sjm.com/mriready NOTE: Certain devices are MR Condition, Adapta Cardiac PacemakerMedtronic, Inc., www.medtronic.com, AngelMed GuardianImplantable Cardiac MonitorAngel Medical SystemsShrewsbury, NJ, Biotronik Cardiac Implantable Cardioverter Defibrillator (ICD)List of MR Conditional VersionsBiotronik, www.biotronikusa.com/manuals/index.cfm NOTE: Certain devices are MR Conditional at 1.5 T and oth, Biotronik Cardiac PacemakerList of MR Conditional VersionsBiotronik, www.biotronikusa.com/manuals/index.cfm NOTE: Certain devices are MR Conditional at 1.5 T and others are MR Conditional at 1.5 and 3, Boston Scientific Cardiac Pacemaker List of MR Conditional VersionsBoston Scientific, www.bostonscientific.com NOTE: Certain devices are MR Conditional at 1.5 T and others are MR Conditional at 1.5 an, Boston Scientific Implantable Cardioverter Defibrillator (ICD)List of MR Conditional VersionsBoston Scientific, www.bostonscientific.com NOTE: Certain devices are MR Conditional at 1.5 T and others ar, Concerto II Cardiac Resynchronization Therapy, CRTMedtronic, Inc., www.medtronic.com, Consulta CRT-D Cardiac Resynchronization TherapyMedtronic, Inc., www.medtronic.com, Consulta CRT-P Cardiac Resynchronization TherapyMedtronic, Inc., www.medtronic.com, Cosmos IIModel 283-03PacemakerIntermedics, Inc.Freeport, TX, Cosmos IIModel 284-05PacemakerIntermedics, Inc.Freeport, TX, CosmosModel 283-01PacemakerIntermedics, Inc.Freeport, TX, Delta TRSType DDDModel 0937PacemakerCardiac Pacemakers, Inc.St. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). The version or model found on the device label or accompanying packaging used to identify a category or design of a device. | NEJM Resident 360 EnCor MRI Directional Vacuum-Assisted Biopsy Device and Driver Bard Biopsy, www.bardbiopsy.com. Apr 20, 2016, 07:00 ET. Indicates the high value for storage and handling requirements. An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. In some cases, the device may not respond to irregular heartbeats or may deliver inappropriate shocks and in rare cases severe complications or device failures can occur. Additional undefined device size not represented in the GUDID Size Type LOV. The number that allows for the identification of a device, indicating its position within a series. MRI exams are safe for some devices MRI (magnetic resonance imaging) uses a large, circular magnet and radio waves to produce clear computer images of the body. Some of these devicesparticularly larger ones, like left ventricular assist devices and some defibrillators and pacemakers can create dense streaks that partially obscure the images we acquire with the CT scan, Dr. Flamm says. Your device, which contains metal,interacts with any detector that responds to metal. INGEVITYTM+:7840, 7841, 7842 All Rights Reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. * When conditions of use are met. 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. An implantable cardioverter defibrillator is designed to monitor and treat heart rhythm problems, greatly reducing the risks associated with them. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Safety Topic / Subject Article Text 167: . Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Version or Model: N140. ENDOTAK RELIANCETM (DF1): 0127, 0128, 0129, 0137, 0138, 0139, 0143, 0147, 0148, 0149, 0153, 0157, 0158, 0159, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187 How does the EMBLEM S-ICD differ from transvenous ICDs? For each patient with an affected device, add the Boston Scientific INGENIO EL Pacemakers and CRT-Ps Physician Letter sent on June 3, 2021 to their medical record to maintain awareness of this topic for the remaining service life of the device. There have been no reports of death. Manufacturer Reason. 2023 Boston Scientific Corporation or its affiliates. Brand Name: ENERGEN ICD. All Rights Reserved. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. An ICD is a small, battery-powered device that holds a tiny computer. More recently, however, manufacturers have developed some pacemakers and defibrillators that can be scanned with an MRI. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. S-ICD ELECTRODES: 3010, 3400, 3401, 3501 Learn about shock therapy. Certain Boston Scientific pacemakers and defibrillators come with an automatic, in-home monitoring system called LATITUDE. Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. While the shock may be painful, it is over in an instant. Reproduced with Permission from the GMDN Agency. : Boston Scientific Corp. N970003 S283: 04/21/2023: cognis, energen, punctua, incepta, origen, inogen,. Brand Name: ENERGEN ICD Version or Model: E143 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 00802526480744 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 106295384 * Terms of Use This means your device is monitoring and responding to dangerous heart rhythm irregularities. Perform a system follow-up remotely or in person at least every 12 months. When will I get my permanent Medical Device ID Card? Visit http://www.bostonscientific.com/imageready for additional information including cardiology/radiology checklists, conditions of use, patient resources, and the MRI Technical Guide. implantable cardioverter defibrillator (ICD), Protecting Your Pacemaker From Smartphones, Power Lines, Planning to Travel? Here, diagnostic radiologistScott Flamm, MD, reviews what you need to knowabout getting medical scans when you have an implanted cardiac device. 1 VITALIOMRI is only MR-Conditional with INGEVITYMRI leads. Boston Scientific Increases Longevity Projections for Its U.S This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. You can adjust your Community Subscriptions in Settings, You can add Community Subscriptions in the search bar that says "Subscribe to more communities ". Brand Name: ENERGEN CRT-D Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 00802526480966 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Cardiac Resynchronization Therapy Defibrillator ENERGEN CRT-D - Device Characteristics On June 3, 2021, Boston Scientific sent all affected customers an Important Medical Device Advisory. 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. The brand name is the name that is typically registered with USPTO and have the and/or TM symbol. However, for individual patients, factors such as those listed above in the previous bullet and shared decision-making may support consideration of early device replacement to prevent unintended outcomes. According to Boston Scientific compatible MRI cans Last update Tuesday, 24 January 2023 EMBLEM S-ICD (A209, A219) Field strength 1,5T full body Exclusion zone No exclusion zone Specific conditions In combinaison with Boston Scientific compatible MRI leads Last update Tuesday, 24 January 2023 Coils, Filters, Stents, and Grafts More.

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