Medtronic MC1AVR1 MRI Technical Manual

Micra™ AV MC1AVR1

MRI procedural information for Micra AV Model MC1AVR1 MR Conditional transcatheter
pacing device implanted in the right ventricle

MRI Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and
possibly in other countries. All other trademarks are the property of their respective owners.

CareLink, CareLink Encore, Medtronic, Medtronic CareLink, Micra, Quick Look, SureScan

Contents

1 Introduction 4

2 MRI conditions for use 4

2.1 Cardiology requirements 4

2.2 Radiology requirements 4

2.3 Training requirements 5

2.4 Patient monitoring and rescue requirements 5

3 MRI warnings and precautions 5

4 Potential adverse events 5

5 Patient monitoring requirements 6

6 Cardiology-specific considerations 6

7 Radiology-specific considerations 6

7.1 MRI considerations 6

8 Pre-MRI scan operations 7

8.1 Identification of the SureScan device 7

8.2 Required patient care 7

9 Performing an MRI scan 7

9.1 SureScan device integrity verification 8

9.2 Programming the MRI SureScan feature to On 8

9.3 Device considerations 9

10 Following the MRI scan of an active device 9

10.1 Returning the active device to the pre-MRI configuration 9

11 Medtronic warranty information 10

12 Explanation of symbols 10

13 Service 10

3

1 Introduction

The Medtronic Micra AV Model MC1AVR1 transcatheter pacing device is an MR Conditional device and, as such,
is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI
conditions for use. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned
while the device continues to provide appropriate pacing. The MRI SureScan feature must be programmed using
a Medtronic programmer and the Micra AV programmer software.

It is important to read this MRI Technical Manual before conducting an MRI scan on a patient with an implanted
Micra AV device. Contact a Medtronic representative if you have further questions.

Note: The button labels and navigation instructions in this manual apply to the Medtronic Model SW044 software
on a Medtronic CareLink Model 2090 Programmer or a Medtronic CareLink Encore Model 29901 Programmer.
The details of the user interface are provided for reference only and may not match those of other applications.

Refer to the appropriate Medtronic device and reference manuals for non-MRI related instructions for
use.

2 MRI conditions for use

The Micra AV transcatheter pacing device is MR Conditional and, as such, allows the patient to undergo an MRI
scan when used according to the instructions in this manual.

Warning: Do not scan a patient who has an active Micra AV device without first programming MRI SureScan to On.
Scanning an active Micra AV device without programming MRI SureScan to On may result in patient harm.

Note: MRI SureScan cannot be programmed to On if the device reaches the Recommended Replacement Time
(RRT).

Note: Micra AV devices can be safely scanned if the device is programmed to Device Off, or if the device has
reached End of Service (EOS). For more information about EOS conditions, refer to the device manual Medtronic
provided for this device.

2.1 Cardiology requirements

Patients implanted with the Micra AV device must be screened to meet the following requirements:

●

No abandoned leads are present.

●

The active SureScan device is operating within the projected service life.

●

Pacing amplitude is ≤ 4.5 V at the programmed pulse width.

●

No diaphragmatic stimulation is observed when MRI SureScan is programmed to On.

●

The SureScan device that is beyond its projected service life is programmed to Device Off.

2.2 Radiology requirements

Scanning patients who have multiple MR Conditional devices present is acceptable when the MR labeling
conditions for all implanted devices are satisfied.

The safety and reliability of the Micra AV device have been evaluated for scanning patients, using MRI equipment
that has the following operating characteristics:

4