Alerta De Seguridad para Medtronic 900 Series Kappa Pacemaker; Implantable Pacemaker Enpulse E2DR Medtronic; Implantable Pacemaker Adapts Medtronic; and Implantable Pacemaker Sensia Medtronic. Records in Anvisa: 10339190170; 10339190183; 10339190183; 10339190277; 10339190278.

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 problem occurrence rate is approximately 1 in 18,000 devices), according to Medtronic. This problem has NO impact on battery life and DOES NOT require removal of the device. Currently the device can be restarted for normal operation by a Medtronic representative and restarted devices are no longer likely to have a recurrence of the problem mentioned. At the end of 2011, following regulatory approval still pending, Medtronic plans to launch an update of the programmer's software that will allow the physician to restart the device. The company also consolidated product performance data with the goal of creating a benchmark tool for performance updates (www.medtronic.com/CRDMProductPerformance), which will provide survival curves, durability tables, performance notes and instructions based on device model and serial number (Serial Number Lookup). Medtronic has received 101 worldwide reports of this problem, out of an estimated 1.8 million devices. Seventy devices were explanted and most explants occurred prior to Medtronic developing a method for restarting devices. #### UPDATE (02/27/2012): The company reports that a programmer software update is already available for the affected devices (except Kappa and EnPulse) to allow doctors to quickly restart ERI Lock-Up. The service tool is still available for Kappa and EnPulse devices. A corrective action completed by Medtronic Ltda. - updated 436 units out of a total of 478 equipment under risk in Brazil (update of 91% of equipment under risk). According to the company, 5 units were stolen and 37 were not located after three attempts to contact customers.