Alerta De Seguridad para Ventak Prizm 2 DR, Contak Renewal and Contak Renewal 2 CRT-Ds, Ventak Prizm AVT, Vitality AVT, Renewal 2 AVT and Renewal 4 AVT.

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.

Brazil 21/06/2005 - Given the seriousness of the situation, ANVISA launched a research process, articulated between UTVIG / GGTPS, GGIMP and CVS / SP, with a view to adopting the pertinent measures to ensure the safety of the medical products offered population in Brazil. Among these measures we highlight the identification of GUIDANT DO BRASIL LTDA as the holder of authorization to market the products of Guidant Corporation / USA in national territory. In Brazil only the Contak Renewal H 135 models were implemented - ANVISA Registration no. 10357240087, canceled on 06/22/2004 and Ventak Prizm II DR 1861 - ANVISA Registry no. 10357240067, canceled on 07/05/2004. The existence of 92 implantable cardioverter-defibrillators at the national level was reported to ANVISA-Tecnovigilance Unit, of which 62 were from VentaK Prizm 2 DR (model 1861) and 30 Contak Renewal (model H 135). ANVISA, through the UTVIG, began monitoring these implantable cardioverter-defibrillators by tracking down the professional users - doctors who performed the implants. This monitoring is being done in conjunction with the company BIOTRONIK Indústria e Comércio Ltda. who is providing assistance in relation to technical matters for the company Guidant ..................................... ............................ COMPLEMENTARY INFORMATION ACCESS: http: //www.anvisa.gov.br/divulga/informes/2005/ 290705.pdf