Safety Alert Or Field Safety Notices for Implantable cardioverter defibrillators (ICD)

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
    Risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately two and an half years after implantation.Approximately 69,000 EnTrust devices have been sold worldwide since 2005, with just over 1,000 sold in the UK. To date only 0.15% of single chamber EnTrust ICDs and 0.04% of dual chamber EnTrust ICDs worldwide are reported to have experienced rapid voltage decline. Although the issue does not appear to affect devices implanted for less than 30 months, the failure rate as implant duration increases is as yet unknown.Medtronic issued a Field Safety Notice (38Kb) addressing this issue on 6 March 2012.Fig 1: Medtronic’s analysis of ICD failures
    The graph shows examples of a number of ICDs which have experienced rapid voltage drop from 3.0V to 2.61V over a time period ranging from approximately one week to six months.  
    Note:  This graph may not be characteristic of every possible voltage curve drop due to this issue.  The sole purpose of this graph is to illustrate rapid voltage decline to 2.61V (ERI), not the duration of time between ERI and EOL.End of life (EOL) is triggered 90 days after ERI or after two excessive charge time events (>16 seconds) or if the battery voltage is 2.55V.In EnTrust devices that experienced rapid voltage decline, time between measurements of approximately 3.0V and 2.61V (ERI) ranged from four to 198 days (mean 71, median 56).In EnTrust devices that experienced rapid voltage decline, time between ERI and EOL ranged from six to 96 days (mean 41, median 26), based upon data available from the 9 ICDs that experienced charge circuit timeout events during automatic capacitor formation prior to device explant.In the event of a battery short circuit the ICD may not be able to provide the required therapy for the three month period generally expected post ERI. Although incidents of charge circuit timeout have occurred, there have been no reports to date of death or serious injury associated with this failure.The rapid voltage drop has been linked to an internal short circuit within the ICD battery.  Although the exact root cause is still being investigated by the manufacturer, the issue appears to be specific to EnTrust devices.  Failure rate data for other Medtronic ICD models incorporating the same battery model currently indicate that they are not affected.  Furthermore, these batteries are not used by other manufacturers.
  • Reason
    (medtronic) once elective replacement indicator (eri) is reached there is a risk of loss of icd/pacing therapy from rapid battery depletion that occurs around 2.5 years after implantation. (mda/2012/014).
  • Action
    Follow-up all patients with EnTrust ICDs urgently: within one month if the device has been implanted for more than 28 months within three months in other cases; in order to: ensure audible alerts for ‘Low Battery Voltage ERI’ and ‘Excessive Charge Time EOL’ are programmed ON (status can be viewed over CareLink) advise patients to contact centres immediately if the alert sounds compare battery voltage with values from previous follow ups for evidence of rapid battery voltage drop (see Fig 1). Replace ICDs where ERI has been reached in the presence of rapid battery voltage drop, within two weeks. Continue to review all patients every three months. Ensure all patients are enrolled on CareLink, in discussion with the manufacturer. Prophylactic replacement of these devices is not recommended except in exceptional circumstances.


  • Model / Serial
  • Product Description
    Implantable cardioverter defibrillators (ICD).EnTrust VR/DR/ATModels: D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, and D154VRC.Manufactured by Medtronic.
  • Manufacturer


  • Manufacturer Address
    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 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