Safety Alert Or Field Safety Notices for Dual Chamber Pacemakers

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Medtronic Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 (675Kb) – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.A copy of the FSN is in the appendix of this Alert, and it is also available on the MHRA website.
  • Reason
    (medtronic ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (reference: fa507). (mda/2011/060).
  • Action
    Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.


  • Model / Serial
  • Product Description
    Dual Chamber Pacemakers.Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia.Vitatron models: E50A1, E60A1 and G70A1.
  • Manufacturer


  • Manufacturer Address
    Lezlie Bridge Medtronic Ltd Building 9 Croxley Green Business Park Hatters Lane Watford WD18 8WW Tel: 07740 899 216 Fax: 01923 225 273Email:
  • Manufacturer Parent Company (2017)
  • 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