Alerte De Sécurité sur Trade name: Double Chamber 2 Step Marker (Ingenio 2). Technical Name: Dual Chamber Implantable Cardiac pacemaker, with Frequency Response. ANVISA registration number: 10341350824. Class of risk: IV. Model affected: L200; L210; L310; S701 .. Serial numbers affected: See attached list on the Anvisa portal at the following link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2450-tecnovigilancia-boston- pacemaker-dual-2-ingenuity-2-problem-fault-in-signal-of-sensor / 33868

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 upgrade designed to automatically detect and resolve this signal over-detection behavior of the MV sensor. Until software is available to automatically resolve MV sensor signal over-detection, Boston Scientific recommends managing the risk for patients implanted with affected pacemaker systems as follows: • For pacemaker dependent patients, change the MV sensor to "OFF". Note that when programmed to passive, the MV sensor signal is enabled and may be over-detected. See Appendix B for details on changing the MV sensor to "OFF". • For all other patients, evaluate the risks of over-detection of the MV sensor signal against the benefits of the pace indicated on the MV sensor. If the risk exceeds the benefit, change the MV sensor to "OFF" (see Appendix B). • If out-of-range, transient, or abrupt changes in RA / RV rhythm impedance measurements are observed, contact Boston Scientific Technical Services to explore all noninvasive programming options before surgery. In most cases, system management can be done non-invasively through schedule changes. • According to the manual of the pacemaker, if MV sensor signal artifacts are observed in EGMs and the electrodes are working properly, consider programming the sensor to "OFF" to avoid over detection. • For patients with the MV sensor enabled, periodically reassess the dependence of the pacemaker. 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: 12/13/2017 - Date of notification notice to Anvisa: 12/28/2017 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. (...) "