Alerta De Seguridad para External Defibrillator, Brand Medtronic, Model Lifepak 500, ANVISA register 10339190062 manufactured between February 2005 and August 2005.

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 Technovigilance Unit - NUVIG / ANVISA is following the actions of the company according to voluntary notification of Medtronic Comercial Ltda. Update (05/15/2006): Medtronic Comercial Ltda informs that the replacements of the equipment will be given until 01/07/2006. ************* Update: 07/20/2006 Medtronic informs that it has begun the recall of the affected products with an expiry date until 08/15/2006. ************* Update 28/08/2006 Medtronic informs the termination of the recall by replacing all notified equipment. Inquiries or clarifications contact the Representative in Brazil, Medtronic Comercial Ltda, (11) 3707-3759, Department of Regulatory Affairs or the Technovigilance Unit / ANVISA.