Safety Alert Or Field Safety Notices for External 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 APC Medical 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 APC Medical E4162, E4164, E4165 and E4166 external pacemaker models incorporate a design feature whereby the pacing rate will increase by approximately 20ppm, when either the battery voltage becomes low, or when electromagnetic interference is sensed. In both instances the mode of pacing changes from demand to asynchronous pacing. The original intention of this design feature was to avoid competitive pacing and pacing on the T-wave (initiating VT/VF), by increasing the set paced rate by approximately 20ppm.Some patients however may not tolerate such a sudden increase in pacing rate, which may be detrimental to their condition (eg open-heart surgery, valve replacement, congestive heart failure, myocardial infarction, arrhythmia etc). MDA became aware of an incident involving one of the above devices, where the design feature initiated an unexpected change in pacing therapy, which could be inappropriate for certain patients. In the device concerned, failure analysis determined an internal component failure in the battery monitoring circuit. This resulted in inaccurate detection of the battery voltage, which was incorrectly sensed as low. This initiated asynchronous pacing and an increase in pacing rate by an additional 20ppm. The clinician concerned was unaware of the device feature.The APC Medical E4162, E4164, E4165 and E416 pacemakers were designed and manufactured over 20 years ago and therefore clinicians may not be familiar with all the instructions for use, which may not be readily accessible. The design feature common to the above models is not widely used in modern external pacemakers, which incorporate different warning systems to alert users to low battery voltage or the presence of electromagnetic interference.MDA has previously advised that some external pacemakers (including APC model E4162) are susceptible to interference from mobile communications systems 1,2,3 and care should be taken to ensure that patients supported via external pacemakers are not exposed to electromagnetic fields from mobile phones, walkie-talkies etc. MDA has also previously advised that older external pacemaker models should be withdrawn and replaced. 4,5 APC Medical advises that E4162, E4164, E4165 and E416 models have a 15-year service life expectancy and recommends their replacement at the end of that period.Consideration should therefore be given to replacing the above models as soon as practicable. Risk managers are reminded of the Controls Assurance Standard - Medical Devices Management (Criterion 18)6, which addresses the replacement of medical devices in detail, extract as follows:For both hospital and community devices, a stage is reached at which replacement must be considered. If any of the following seven criteria apply, the device is no longer serviceable:Worn out beyond economic repair
    Damages beyond economic repair
    Unreliable (check service history)
    Clinically or technically obsolete
    Spare parts no longer available
    More cost-effective or clinically effective devices have become available
    Unable to be cleaned effectively prior to disinfection and/or sterilisation”
  • Reason
    (apc medical ltd) the pacing rate for models e4162, e4164, e4165 and e4166 may increase by 20 pulses per minute and change in pacing mode in some cases. (mda/2003/008).
  • Action
    Be aware that the above external pacemakers will revert to asynchronous mode pacing at a rate of approximately 20 ppm above the pre-set pacing rate, when either the battery voltage is low or electromagnetic interference is sensed. Ensure that the above devices are not used for patients where a sudden increase in paced rate of 20 ppm, or a change from demand to asynchronous mode pacing, could compromise patient health. Consider replacing the above pacemaker models (which were designed and manufactured over 20 years ago) as soon as practicable. When the above external pacemakers are used, ensure also that mobile communication devices are not used in the vicinity, especially during patient transfer.


  • Model / Serial
  • Product Description
    External Pacemakers: Models - E4162, E4164, E4165 and E4166 (manufactured by APC Medical Ltd)
  • Manufacturer