FDA MedWatch – Assurity and Endurity Pacemakers by Abbott (formally known as “St. Jude Medical”) : Class I Recall

• A loss of device pacing
• Telemetry failure or errors in information
• Early and fast battery drain
• Less time between the first battery depletion warning (elective replacement indicator or ERI) and the device’s end of service (EOS)

If the device is unable to deliver pacing, patients may experience slow or irregular heartbeat, fainting, shortness of breath, tiredness, dizziness, or discomfort. Additionally, shorter battery life and device life may lead to an additional pacemaker replacement procedure sooner than expected. Finally, if the system does not relay accurate information via telemetry, medical providers may not know to provide treatment.

There have been 135 complaints, 135 injuries, and no deaths reported for this issue.

• No recommendation for replacing the device if there is no evidence of the issue, due to a low rate of occurrence and low potential for patient harm as long as a replacement is completed if the device issues an unexpected ERI/EOS alert.
• Routine follow-up per standard of care and clinical protocol, to include:
  • A review of any device function impacts such as battery voltage or any unexpected change in battery consumption.
  • Evaluating the potential risk for patients who are pacemaker dependent and unable to be reliably followed using remote monitoring.
• Prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
• If possible, use Abbott’s Merlin.net patience management system for patient monitoring to receive alerts between routine device checks. Remind patients of the importance of using remote monitoring.