Sam Brusco, Associate Editor05.17.21
Abbott is recalling a subset of Assurity and Endurity pacemakers built using specific manufacturing equipment and distributed from April 2015 to February 2019. A small number of devices from that time frame have experienced problems when moisture is able to get inside the device. The moisture can cause an electrical short, that may lead to:
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 doesn’t relay accurate information via telemetry, medical providers may not know to provide treatment.
There have been 135 complaints, 135 injuries, and no deaths reported thus far.
On March 15, Abbott sent customers a letter informing them of the issue and providing patient management guidelines.
There is 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 will include review of any device function impacts such as battery voltage or any unexpected change in battery consumption, evaluating the potential risk for pacemaker dependent patients unable to be reliably followed using remote monitoring, and prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
If possible, the company advises using its Merlin.net patient management system for patient monitoring to receive alerts between routine device checks, as well as to remind patients of the importance of using remote monitoring.
- 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 doesn’t relay accurate information via telemetry, medical providers may not know to provide treatment.
There have been 135 complaints, 135 injuries, and no deaths reported thus far.
On March 15, Abbott sent customers a letter informing them of the issue and providing patient management guidelines.
There is 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 will include review of any device function impacts such as battery voltage or any unexpected change in battery consumption, evaluating the potential risk for pacemaker dependent patients unable to be reliably followed using remote monitoring, and prompt replacement for devices that reach ERI or EOS unexpectedly or experience a clinical impact.
If possible, the company advises using its Merlin.net patient management system for patient monitoring to receive alerts between routine device checks, as well as to remind patients of the importance of using remote monitoring.
