Safety Alert for Trade name: S-ICD Pulse Generator; Emblem Pulse Generator MRI S-ICD. Technical Name: Cardioverter and Implantable Defibrillator. ANVISA registration number: 10341350828. Class of risk: IV. Affected model: A209, A219 and 1010. Affected serial numbers: 119691, 119606, 119566, 118807, 118834, 119432, 119057, 118820, 117674, 115213, 115422, 115071, 115119, 116516, 112631, 119489, 115442, 119495, 120089, 119892, 119893, 119923, 120009, 120040, 120076, 120217, 120479, 120485, 120493, 120576, 102588, 101736, 119845, 119802, 119721, 119587, 116882.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

In consultation with our Patient Safety Deliberative Council, Boston Scientific recommends NO change to clinical follow-up due to this unique event. Specifically for patients with S-ICD systems: • Continue to use the S-ICD system to detect and treat ventricular tachyarrhythmias at risk of death; • Keep LATITUDE ™ programmed and / or in clinical follow-ups; and • Follow the precautions identified in the S-ICD user manual when radiation therapy is prescribed. In addition, Boston Scientific DOES NOT recommend the following: • Early or out-of-cycle follow-up. This type of memory corruption can not be detected, so additional S-ICD checks do not reduce the potential for behavior of this device. • Prophylactic substitution or explant of S-ICD. The risks associated with such an additional surgical procedure significantly outweigh the risk of recurrence of the behavior of this device. Until software mitigation update is available, this S-ICD behavior represents a small additional risk that should be considered when assessing the relative risks associated with all available DCI therapy options. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 06/30/2017 - Date of notification notice to Anvisa: 06/07/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "