SA Heart's response to recent media information on pacemakers

Published: Sep 13, 2017

There have been reports in the media about a United States Food and Drug Administration alert on some models of St Jude pacemakers.

The threat is a theoretical one. There are no reported cases of "hacking" of any pacemaker. The FDA is being pro-active in pointing out a possible (and unlikely) vulnerability in device communications.

The alert is to raise the awareness of devices that have the ability to communicate with systems such as bedside monitors. This communication may be vulnerable to interception and manipulation if the bedside monitor has been compromised by a cyber-attack.

The pacemakers are not defective and have not been recalled, they do not need to be replaced and you are not in danger.

At this stage there is no alert on other pacemaker company devices, (e.g., Medtronic, Biotronik, or Boston Scientific).
This alert applies only to the St Jude pacemakers listed below

  1. Accent RF 
  2. Assurity RF 
  3. Anthem RF
  4. Allure RF

You can check which device you have by looking at the pacemaker card you were sent out after the pacemaker was implanted. If it is not one of the devices listed above you are not affected.

St Jude (Abbott) have issued a software patch that will be used to close the vulnerability for these pacemakers. This software patch will require patients with the devices listed above to come in for a device check and have the software upgrade performed which will fix the problem.

SA Heart takes this alert very seriously and is working with St Jude Medical / Abbott to identify which SA Heart patients have a device that needs a programming change. You will be contacted if you are affected by the alert and arrangements will be made to organise a time to perform the programming change, this may be at the next scheduled check or earlier if your cardiologist thinks that it is necessary. It is important to remember that this is a precautionary alert and you are not in danger.

The links below are provided by the FDA for further information

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm573854.htm

Abbott has a website for more information (St Jude Medical were recently acquired by Abbott medical and are now called Abbott).

www.sjm.com/cyberupdate

 



 

 

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