Abbott Advisory: For a Subset of AVEIR VR leadless Pacemakers Manufactured Prior to February 1, 2024

Impacted Models

AVEIR™ VR LEADLESS PACEMAKERS, MODEL LSP112V manufactured prior to February 2024 with firmware version 19.05.00.

Issue Summary

AVEIR™ VR leadless pacemakers manufactured prior to February 2024 with firmware version 19.05.00 have the potential to undergo a mode change due to environmental EMI (electromagnetic interference). The pacemakers have been noted to enter either EVVI or MRI mode. The parameters for EVVI mode are VVI pacing at 6 V @ 0.6 ms and 70 bpm, and MRI mode is VOO mode at 5 V @ 1 ms and 85 bpm.  The increased pacing output and rate of these modes may substantially reduce device longevity. There have been no reports of permanent harm to patients due to this issue.

Each month of operation in either of these modes is estimated to consume 8% of the device’s initial battery capacity. If the device is left to operate entirely in these modes, the service life for the pacemaker from new will be approximately 13 months. 

At present, Aveir leadless pacemakers cannot be followed remotely. Therefore, the issue can only be detected in an in-person clinic encounter with a Merlin programmer. If affected, the patient will present in either Emergency VVI (EVVI) or MRI (VOO) mode. 

Of the 12,000 AVEIR VR devices subject to this notification, 4 patients (0.034%) reported the sensation of an elevated heart rate consistent with the mode change; whereas 13 other patients (0.112%) presented with the mode change and were asymptomatic.  Two devices (0.017%) were found to be at RRT prematurely and needed to be replaced. 

This issue is corrected through a firmware upgrade to 19.12.00. Following the firmware upgrade, the implanted device will be equivalent to newly manufactured devices.  Zero devices with the updated firmware 19.12.00 have experienced the mode change issue.

Abbott Recommendations

Abbott is providing the following guidelines:

1. Prophylactic device replacement is NOT recommended as the new firmware version obviates the potential for this mode change and loss of device longevity. Following firmware upgrade, the implanted device will be equivalent to a newly manufactured device.
2. During in clinic follow-up (preferably within 3 months of this notification) upgrade to the LSP112V firmware is suggested. 

-For most devices, the upgrade will execute automatically when interrogated. If necessary, contact Abbott CRM technical support.

-If the device presents in MRI or EVVI mode, reprogram the device 

HRS Recommendations

HRS strongly encourages its members worldwide to read the Abbott Safety Notification. For patients implanted with these devices, we strongly recommend the firmware upgrade to mitigate the risk of this malfunction. We agree with Abbott that prophylactic device replacement is not recommended.

Reporting Adverse Reactions or Quality Problems

Adverse reactions or quality problems experienced with the use of this product 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

The Instructions for Use has content available regarding potential EMI sources.

During the upgrade if any issues are encountered, or if further support is required, contact Technical Services at 1-800-722- 3774 (U.S.).

A list of Abbott advisories is available at www.cardiovascular.abbott/us/en/hcp/product-advisories.html.