Product Education Brief: Micra™ TPS Monitoring and End of Service Behavior

Micra TPS devices
Original Date of Communication: January 2025

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Overview

This Product Education Brief provides a description of specific monitoring and follow-up recommendations, including a description of end of service behavior.

This Product Education Brief is consistent with existing labeling and reiterates precautions listed in the product’s Instructions for Use (IFU).

Micra Instructions for Use

The Micra IFUs are available on the Medtronic electronic manuals website (manuals.medtronic.com).

Monitoring, Follow-Up, and End of Service

Remote monitoring of patients with a Micra device is recommended in the 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement.

The 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic states that in patients with CIEDs, remote monitoring (RM) is recommended as part of the standard of care. The consensus statement advises that patients with CIEDs on RM, in the absence of continuous connectivity, such as with Micra, remote transmissions are recommended at least every 3-12 months. It is also noted that there are some circumstances (e.g., if a patient is pacemaker dependent) where the transmission frequency may match or exceed every 3-6 months. As the device approaches elective replacement, the frequency of transmissions should be increased to every 1-3 months. The frequency recommendations apply whether the patient transmits data remotely or has an in-office visit.

Following recommended replacement time / elective replacement indicator (RRT/ERI) and as described in the IFU, the Micra device sets battery end of service (EOS) after measuring voltage ≤2.5V on 3 consecutive daily automatic measurements. When the Micra device reaches EOS, it permanently deactivates pacing and switches to the Device Off mode. This EOS mode differs from Medtronic transvenous pacemakers. The IFU indicates that the estimated time from RRT to EOS is 6 months, and the approximate time from ERI to EOS is 3 months. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, MRI conditions for use, and potential complications/adverse events.

Product Performance

Medtronic monitors and evaluates product performance, including battery performance, for all Micra devices. The device performance data is published on our product performance website productperformance.medtronic.com. Reports of Micra premature battery depletion and normal battery depletion are included on the product performance website.

In addition, Medtronic continues to collaborate with physicians and regulatory agencies to improve patient outcomes and clinical experience as part of our dedication to patient safety and product effectiveness.

References

• medtronicacademy.com
• Micra MC1VR01 Clinician Manual - M042502C001
• Ferrick, A. M., et al. (2023). 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Europace, 25(5), euad123.

Specific Models This Applies To