Abbott Advisory: Merlin Patient Care System Software Anomaly When Used with AVEIR DR Leadless System

Impacted Models

MERLIN™ Patient Care System PCS) 3650 Software Model 3330 V28.0.X – V28.1.X REV 1 when used with Aveir™ DR Leadless System.

Issue Summary

During the Finalize the New LP (“Finalization”) step of an upgrade of Aveir VR to Aveir DR or implantation of a new AVEIR DR system, loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. This leads to a loss of pacing. At that point, full functionality, including ability to finalize the device and restore pacing, can only be accomplished with the help of Abbott Technical Services.

If this issue occurs, the Merlin programmer displays “Loss of telemetry detected” window, and there is no pacing. Atrial sense markers coincident to intrinsic QRS complexes may also be observed.

This issue has been observed at a rate of approximately 0.2% globally. There have been no reports of patient harm with any of these events, and devices have all been successfully restored to standard functionality with the help of Abbott technical services.

Updated Merlin PCS 3650 programmer software (version 28.2.4 rev 1 or higher) completely prevents this issue. To prevent the rare risk of inappropriate LP programming during system upgrades, this updated, corrected software version should be incorporated into your Abbott Aveir implanting programmers before AVEIR DR system implants or VR system upgrades. In the United States, the software has already become available, and Abbott representatives are working with implanting facilities to update programmers. Software upgrades are anticipated by the beginning of 2025 in Europe and Asia, and by mid-year 2025 in Canada.

Abbott has notified the applicable regulatory agencies including the FDA about this matter.

Abbott Recommendations

Updated Merlin™ PCS 3650 programmer software (version 28.3.2 rev 1 or higher) prevents this issue. This software is already available in the United States, it is anticipated to become available in January of 2025 in Europe and Asia, and mid-year 2025 in Canada. Please work with your local Abbott representative to update the programmer software as it becomes available.

Abbott is providing the following recommendations for implanting AVEIR DR LPs prior to the programmer software upgrade:

1. Prior to finalization, ensure robust telemetry connection.
2. For pacemaker dependent patients: Consider backup pacing support through implant finalization.
3. During a new AVEIR DR system implant, consider implanting and finalizing the RA LP first before the RV LP if appropriate for the patient, as this order of finalization does not allow the issue to occur.

If this issue occurs during the finalization step of an AVEIR DR system, contact Abbott Technical Services as device restoration will be required. Your local Abbott Representative can help to contact Abbott Technical Services on your behalf.

HRS Recommendations

HRS strongly encourages its members to work with their Abbott representatives to ensure that the software upgrades are installed when they become available. This is expected to completely remedy the problem. In the interim, we also agree with the Abbott recommendations provided above.

Reporting Adverse Reactions or Quality Problems

Adverse reactions or quality problems experienced in the United States should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Should you have any questions about this notice, contact Abbott Technical Services at 1-800-722-3774 (U.S.) or +4684744147 (Europe).