Alerta De Seguridad para EXTERNAL DEFIBRILLATORS: LIFEPAK 12 (Anvisa Reg. 10339190080); LIFEPAK 20 (Anvisa Reg. 10339190171); LIFEPAK 500 (Anvisa Reg. 10339190062); LIFEPAK 1000 (Anvisa Reg. 10339190300); LIFEPAK CR PLUS (Reg Anvisa 10339190167).

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.

The term of the permanent prohibition agreement signed on April 25, 2008 by Physio-Control Inc./Medtronic Inc. restricts the shipment of manufactured products to the Redmond, WA facility due to deficiencies in the Good Manufacturing Practices system verified in inspections performed by the FDA. According to information from ECRI and Medtronic Comercial Ltda, the shipment of products from the Redmond, WA plant to the US market has been voluntarily suspended since January 2007. With the signing of the permanent ban company is prohibited from manufacturing, distributing and exporting Automated External Defibrillators (see Product Description field) until Redmod equipment and plant are in accordance with Good Manufacturing Practices. Despite this, the company is authorized by the FDA to conduct a limited selection of products to meet critical customer needs on emergency occasions when necessary. The Anvisa Technovigilance Unit has already initiated a contact with Medtronic Comercial Ltda (holder of product registrations in Brazil). #### Update (12/03/2010): According to information presented by Medtronic Comercial Ltda, the prohibition established by the consent decree was withdrawn by the US FDA on 02/18/2010.