Medtronic Reveal LINQ™ LNQ11 Insertable Cardiac Monitor

Informationen zu MRT-Untersuchungen

[MR Symbol] MR Conditional

1 Introduction

The Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) Model LNQ11 is conditionally safe for MRI and designed to allow safe scanning with a Magnetic Resonance Imaging (MRI) device. Preclinical testing has shown that the Reveal LINQ can be safely used in the MRI environment when the following MRI usage conditions are met. Before performing an MRI scan on a patient with an implanted Reveal LINQ device, the radiology and cardiology personnel involved in the scan should familiarize themselves with the requirements and instructions in this User Manual. For questions, contact your local Medtronic representative or Medtronic using the addresses and phone numbers listed on the back cover.

2 MRI Procedures Prerequisites

The following symbol indicates conditional MRI compatibility, referring to the Magnetic Resonance Imaging (MRI) environment and indicating the conditional safety of devices and components in the MRI environment.

[MR Symbol] Symbol of conditional MRI safety.

The Reveal LINQ device can be safely scanned under the following conditions: Failure to comply with these usage conditions can be dangerous for the patient during an MRI scan:

The proton MR system magnetic field static field must be 1.5 Tesla (T) or 3.0 T.
The open cylinder magnet with static magnetic field must have a strength of 1.5 T or 3.0 T; a maximum spatial gradient of 25 T/m (2500 Gauss/cm) must be used.
For whole-body gradient systems with slew rate specification, the value must be ≤200 T/m/s per axis.
The whole-body Specific Absorption Rate (WB-SAR) reported by the MR device must be ≤4.0 W/kg; the Head SAR reported by the MR device must be ≤3.2 W/kg.
There are no restrictions on the use of local transmit or receive coils for imaging the head or extremities. Do not use transmit coils on the thorax, torso, or shoulder area. There are no restrictions on the placement of receive-only coils.

3 Possible Side Effects

Possible adverse events during MRI scans on Reveal LINQ patients are not known.

4 Cardiology Tasks Before and After the MRI Examination

Note: For information on using a Reveal LINQ device unrelated to MRI scans, such as implantation procedures and programming instructions, cardiologists can refer to the Reveal LINQ ICM User Manual for Physicians.

Before a radiologist performs an MRI scan on a patient with a Reveal LINQ device, the cardiology personnel should perform the following tasks:

All relevant information about the implanted Reveal LINQ device, such as model designation, model number, and serial number, recorded in the patient file and displayed on the patient data screen of the Medtronic CareLink programmer, must be provided to the radiologist. Patient files must be complete and accurate, as radiology will use the records to ensure that the patient has a Reveal LINQ device and does not have any other devices, leads, or implanted items that pose a known risk in the MRI environment. If you have questions about whether an MRI scan should be performed on a specific patient, contact Medtronic at the phone number listed on the back cover.
Data stored in the Reveal LINQ device can be queried using the programmer and saved to a storage medium. The MRI scan could damage the data recorded in the Reveal LINQ device.

After an MRI scan is performed by a radiologist, Medtronic recommends that the cardiologist delete the data captured during the MRI scan, as the MRI scan may have affected the event detection and recording of the Reveal LINQ device. Data deletion can occur as soon as it is possible for the patient and cardiologist.

5 Radiological Requirements

Before an MRI scan is performed on the patient, the radiological personnel should ensure that the following requirements are met:

The MR device meets all requirements specified in Chapter 2, “MRI Procedures Prerequisites”, page 5.
All cardiology tasks before the scan have been completed (for more information, see Chapter 4, “Cardiology Tasks Before and After the MRI Examination”, page 5).

If there are questions about whether an MRI scan may be performed on the patient, the radiological personnel should contact the patient's cardiologist. The cardiologist may need to seek further advice from Medtronic.

An X-ray of the Reveal LINQ device, as shown in Figure 1, can be used to determine if a patient has a Reveal LINQ device (normally implanted in the left thoracic area).

Figure 1. Anterior and lateral X-ray of an implanted Reveal LINQ device

6 Possible Effects of an MRI Scan

The design of the Reveal LINQ device and the MRI usage conditions (described in Chapter 2) limit the possible effects of an MRI scan to the following points. The stated effects do not lead to patient injury or device damage.

MRI Interactions – Due to the static magnetic field and gradient magnetic field generated by the MR device, the magnetic material of an implanted device may exert pressure, vibration, and lever effects that the patient may feel. The gradient magnetic field and the modulated RF field can induce currents and voltages in the device, which can lead to tissue heating, nerve stimulation, and electrical stress on the device components. The gradient magnetic field and the modulated RF field can induce voltages in the sensing circuit, which can affect perception and event detection, and thus lead to the capture of inappropriate data by the Reveal LINQ device.

Image Distortion and Artifacts – The Reveal LINQ device causes image artifacts within the image areas surrounding the implanted device. When selecting the field of view and imaging parameters, as well as when evaluating the MRI scans, image artifacts and distortions resulting from the presence of the device within the field of view should be taken into account.

7 After the MRI Examination

Radiological and cardiology personnel must ensure that all cardiology tasks are performed after a scan (for more information, see Chapter 4, “Cardiology Tasks Before and After the MRI Examination”, page 5).

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