Alerta De Seguridad para Implantable Defibrillator Software:. EPIC HF V-339. EPIC + V-196. EPIC + V-236. EPIC + HF V-350. ATLAS + V-193. ATLAS + V-243. ATLAS + HF V-341. ATLAS + II V-268

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.

Since July 2002 around 143,000 CDIS of the EPIC and ATLAS families have been implemented around the world, and around 123000 remain active today. To date, eight devices (among the 143,000) that have lost ventricular sensing have been detected - the risks detrimental to the patient are in the order of 1 in 1 million. The loss of ventricular sensing was attributed to a well-defined but extremely rare timing sequence that occurs in a very short time window (61 microseconds). To date, there have been no reports of injury or death of any patient to St Jude Medical because of the problem cited. According to St. Jude Medical Ltda, a simple software updater of the generator programmer / firmware will solve the problem, being possible, according to information presented by the company, the software update of both implanted equipment and those not yet implemented . For more details, consult the informative letter provided by St. Jude Medical Ltda (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta900_carta.pdf). The Anvisa Technovigilance Unit is following up on this case. ## Update (09/03/2009): St. Jude Medical Brasil Ltda informed the UTVIG / Anvisa on 03/12/2008 about the completion of the updating process of the mentioned defibrillators this alert.