Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1055
  • Date
    2011-04-25
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The equipment may read the battery voltage incorrectly as zero. this problem is caused by a random hardware lock of the equipment metering system.
  • Action
    The company has already sent letters of communication to the Brazilian Society of Cardiac Arrhythmias (SOBRAC) and to the Department of Artificial Cardiac Stimulation of the Brazilian Society of Cardiovascular Surgery (DECA).

Device

Medtronic 900 Series Kappa Pacemaker; Implantable Pacemaker Enpulse E2DR Medtronic; Implantable P...

Manufacturer

Medtronic Comercial Ltda.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA