Abbott Advisory: Manufacturing Defect Associated with Loss of Pacing for a Limited Subset of 455 Assurity™ and Endurity™ Pacemakers Distributed in Germany, France, the United Kingdom, Spain, and Italy

Impacted Models

A subset of Assurity™ and Endurity™ pacemakers distributed in Germany, France, the United Kingdom, Spain, and Italy.

MODELS PM2152, PM2162, PM2172, PM2272

Issue Summary

Abbott’s product performance surveillance processes have discovered a fault in the manufacturing process within a single piece of equipment, for one of its product manufacturing lines, in a single factory. This manufacturing defect can result in the potential for moisture ingress into the pulse generator. The impacted devices were manufactured between August 2018 and November 2019. The specific equipment which led to this issue is no longer part of the device manufacturing line.

The issue has been associated with interrupted functionality such as loss of pacing, reduced battery longevity, reverting to back-up mode, loss of telemetry / communication, and/or shortened duration between Elective Replacement Indicator (ERI) and End of Service (EOS).

Thus far, nine devices (of this 455 subset) have shown malfunction by this manufacturing defect, with no reports of permanent harm or death to patients so far. Therefore, the rate of device malfunction is 2% at present – but could increase if additional devices manifest malfunction. Abbott estimates the potential rate of any permanent patient harm to be 0.2% at present (assuming 10% pacing-dependence).  The functionality interruption may occur within a week from the last transmission date in Merlin.net. 

Abbott Recommendations

Abbott is providing the following recommendations, recognizing that each patient has unique considerations:

1. Consider generator replacement for patients at risk for significant symptoms or harm if pacemaker malfunction were to occur.
2. Monitor patients using Merlin.net to benefit from compliance and alert monitoring, including Electronics Performance Indicator (EPI – see description below), between routine device checks.
3. Prompt replacement for devices that receive an EPI notification, or reach ERI/EOS, or experience one of the clinical impacts listed above, unless particular patient circumstances preclude this.

EPI (Electronics Performance Indicator) Description

The EPI tool is an Abbott surveillance tool that reviews data from all devices within this affected population via Merlin.net. If an EPI signal is detected, Abbott will notify the clinic using the email contact information in Merlin.net. 

HRS Recommendations

HRS strongly encourages its members worldwide to read the Abbott Safety Notification, including members in the United States who may be following patients implanted with these affected devices from other countries. Given the present rate of device malfunction and possible increase over time, HRS agrees with the Abbott recommendation to consider generator replacement for patients at risk of significant symptoms or harm if pacemaker malfunction were to occur. Specifically, generator replacement is reasonable when the risk of generator malfunction outweighs the risk of device replacement.

Additional Information

As an additional resource, a device lookup tool has been made available and can aid you or your practice in confirming impact for those patients you are following. The U.S. FDA is not expected to issue advice regarding this advisory since the affected devices were not distributed in the United States.

Reporting Adverse Reactions or Quality Problems

Adverse reactions or quality problems experienced may be reported directly to Abbott. If you have any questions about this notice, please contact your local Abbott Representative. In addition, please work with your Abbott Representative to return any explanted devices to Abbott for product evaluation and analysis.