Boston Scientific does not recommend preventive replacement for affected devices. There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. [8] An official website of the United States government, : The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Our patient services team is here to support you throughout your journey. Visit: IMRSER.org MRI Safety Videos Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Implantable Cardioverter Defibrillators - Important Safety Information. The unit of measure associated with each clinically relevant size. Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Not every patient can be scanned, though many now can as long as, all of theproper safetymechanisms are in place, he says. Although the scan will not affect your device, ifitson the larger side, your device can sometimes affect image quality. Apr 20, 2016, 07:00 ET. ACUITYTM Spiral: 4591, 4592, 4593 The device is exempt from Direct Marking requirements under 21 CFR 801.45. Everything you need to know about living with a subcutaneous or transvenous defibrillator device. In patients with an implanted ICD (Figure 4, Supplementary material online, Movie 1), the conventional LGE tech- nique led to 69.2% (53.8-92.3%) artefact-free segments with a wide range of. We may therefore limit the time we spend scanning apatient and limit the kinds of images we acquire. Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b). 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. 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
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