Alerta De Seguridad para Name: Defibrillator for Cardiac Resynchronization Therapy MRI. Technical Name: Implantable Defibrillator for Cardiac Resynchronization Therapy. ANVISA registration number: 10341350864. Class of risk: IV. Affected Model: G158 .. Serial Numbers Affected: See attached list on the Anvisa website - link :. http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2451-tecnovigilancia-boston-fibrillator-for-therapy-of-resynchrony-cardiac-mi--problem- in-stimulation-of-rhythm-biventricular / 33868? p_p_auth = xJO1qIf7 & inheritRedirect; = false & redirect; = http% 3A% 2F% 2Fportal.anvisa.gov.br% 2Final-techniques13% 3Fp_p_auth% 3DxJO1qIf7% 26p_p_id% 3D101_INSTANCE_WvKKx2fhdjM2% 26p_p_lifecycle% 3D0% 26p_p_state% 3Dnormal% 26p_p_mode% 3Dview% 26p_p_col_id% 3Dcolumn-3% 26p_p_col_pos% 3D1% 26p_p_col_count% 3D5

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.

Boston Scientific is actively developing a software update designed to avoid programming a parameter-sensitive combination, the accompanying programming recommendations eliminate the risks associated with early device replacement due to this behavior of the device. CRT devices most commonly programmed for simultaneous BiV pace pacing (LV offset = zero) or sequential BiV where LV precedes RV (negative LV compensation value) are not subject to the risks described in this letter. 1. Review the patient schedule records deployed with the CRT devices included in Appendix B of the Charter. 2. If the LV Compensation parameter is set to Zero or a Negative value, the device is not at risk of this behavior. 3. If the LV Compensation parameter is set to a Positive value, determine whether the following conditions are met: A. The positive LV Compensation value exceeds the Ventricular Atrial Post-Ventricular event, where blanking "Smart" is equivalent to a value of 37.5 ms; and B. Scheduled Trace Preference for ON 4. For patients whose device has a LV Compensation value exceeding the Atrial Blanking value after ventricular event, the Trace Preference is set to ON, schedule a clinical review to reprogram the CRT device as follows, according to the individual medical needs of the patient: A. Program the CRT device so that the post-ventricular Atrial Blanking is greater than the value of the positive LV Compensation; or B. Disable the Trace Preference by programming it to a value of "OFF". 5. Devices with an Atrial Blanking post-event ventricularexcedendo the value of Positive LV Compensation are not affected and are not at risk of this behavior. 6. Patients whose device has the Scheduled Tracking Preference OFF are not affected and are not at risk from this behavior. If a positive LV Compensation is desired for a newly implanted Boston Scientific CRT device, consider the patient's individual medical needs and schedule the ventricular post-ventricular Atrial Blanking greater than the value of Positive LV Compensation, or disable the Trace Preference by scheduling it to "OFF". 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