Safety Alert Or Field Safety Notices for Some EnRhythm® and EnRhythm MRI™ implantable 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.

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
    Following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some EnRhythm® and EnRhythm MRI™ devices.The manufacturer issued a Field Safety Notice (34Kb) (FSN) in August 2011 with patient management recommendations updated from a previously issued FSN (in February 2010), which informed healthcare professionals about a software update.The software update adds a battery impedance ERI threshold that may trigger an unexpected ERI in some devices. Medtronic’s modelling from collected data estimates that approximately 6–10% of devices may reach ERI within five years of implantation. When ERI is triggered, the device reverts to VVI back-up pacing mode (65 beats per minute) which may not be adequate treatment and may cause symptoms associated with pacemaker syndrome for some patients.These pacemakers are no longer sold in the UK and all devices supplied in the UK reached their use by date by 14 August 2011.
  • Reason
    (medtronic) a software update of the new battery impedance elective replacement indicator (eri) threshold may trigger an unexpected eri. (mda/2011/097).
  • Action
    Schedule all patients who have received the software update for a follow-up visit to identify devices that triggered ERI shortly after the software update. Patients who have not yet received the software update should be reviewed, and then again within 90 days after the software update to identify if ERI is triggered.  Continue to follow up until device is ready for replacement: every three months if patient is pacemaker dependent, and every six months (or at individual physician’s discretion) if patient is not pacemaker dependent. Schedule device replacement when ERI is triggered.


  • Model / Serial
  • Product Description
    Implantable pacemakers manufactured by Medtronic.EnRhythm®: Model P1501DR is a dual chamber rate responsive pacemaker.EnRhythm MRI™ SureScan: Model EMDR01 IPG is a modified EnRhythm® P1501DR which is MR Conditional.
  • Manufacturer


  • Manufacturer Address
    Dr David Dunham / Mrs Lezlie Bridge Medtronic Limited Building 9 Croxley Green Business Centre Hatters Lane Watford WD18 8WW Tel: 01923 212 213 / 07740 899 216 Fax: 01923 241 004 / 01923 225 273Email: or
  • 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