Abbott ZenexTM, AssurityTM, and EndurityTM Pacemakers Manufactured Outside the U.S.

Safety Notice Regarding Subset of Abbott Zenex^TM, Assurity^TM, and Endurity^TM Pacemakers

August 1, 2022: Abbott is notifying clinicians of the potential for device malfunction which may impact a specific subset of pacemakers of Zenex^TM, Assurity^TM, and Endurity^TM families. The types of malfunctions noted include loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry /communication. Up until June 2022, the observed rate has been low at 0.15% and there have been no reports of permanent harm nor deaths.  These devices were distributed and implanted in geographies outside the United States.

Issue Summary

A manufacturing laser surface preparation subprocess (unique to a single assembly line in a single manufacturing plant) may not have properly prepared the device’s metal housing, potentially leading to abnormal device-to-header adhesion or loss of hermeticity. This in turn may allow moisture ingress into the pulse generator header. This specific manufacturing process is no longer in use. There are 83,000 specific serial numbers, manufactured at a single plant, which are potentially susceptible to this issue. None of these devices were distributed or implanted in the United States. Impacted devices that remain on shelves have been recalled.

To date, one hundred twenty-eight (128) complaints have been identified. On average, functionality interruption was noticed after 2.1 years of implant duration and may occur as soon as within a week from the last normal transmission in Merlin.net (i.e., function change could occur with little warning). The reported clinical impact has included loss of pacing, reduced battery longevity, devices reverting to back-up mode, and/or loss of telemetry / communication.

Abbott Recommendations

Recognizing that each patient requires individual consideration by their physician, in consultation with Abbott CRM’s Medical Advisory Board (MAB), Abbott provides the following guidelines:

1. Prophylactic generator replacement is NOT generally recommended.
2. When possible, monitor patients using Merlin.net and specifically the EPI tool described below.
3. Consider individualized therapy up to and including generator replacement for patients who are at high risk if interruption of pacemaker function were to occur, potentially considering
   • Adequacy of intrinsic / underlying rhythm
   • Individual patient characteristics and circumstance
   • Ability to adequately monitor patients based on risk
4. Prompt replacement for devices that receive an EPI notification, reach ERI, or experience one of the clinical impacts listed above, unless patient circumstances preclude this.

EPI (Electronics Performance Indicator) Tool

The EPI tool is an Abbott surveillance process that reviews data from all devices within this affected population communicating with Merlin.net. The EPI tool supplements ERI using data available on Merlin.net to identify abnormal electrical system behavior resulting from loss of hermeticity. 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 (including Canada). For patients implanted with the affected devices, we strongly recommend regular remote monitoring if available. If remote monitoring is not available, consideration should be given to more frequent clinic device checks (for example: every 3 months). We agree with Abbott that the decision to replace the generator should be individualized based on the considerations outlined above.

Reporting Adverse Reactions or Quality Problems

Adverse reactions or quality problems experienced may be reported directly to Abbott. Should you have any questions about this alert, 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. The U.S. FDA is not expected to issue advice regarding this advisory since the affected devices were not distributed in the United States.

Adverse reactions or quality problems experienced with the use of this product should be reported to Abbott and to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, or by fax.

• Complete and submit a report online by clicking on “Report a Problem.”
• Call 1-800-332-1088 to request a reporting form or download the form here. Forms may also be mailed or faxed.

For additional questions, contact your local Abbott Representative or Abbott Technical Services at 1-800-722-3774.