MRI Safety Information

Important MRI Safety Information 

Magnetic resonance imaging (MRI) may be safely performed under certain conditions on a patient with a Freedom Stimulator System (SCS/PNS). However, the Transmitter Assembly unit (i.e., the external transmitter and antenna components of this neuromodulation system) MUST NOT be present in the MRI system room at ANY TIME. Failure to adhere to the specific requirements described in this manual can result in tissue damage, severe injury, or death.

 

Preparation for an MRI 

The following steps are required before performing an MRI procedure on a patient with an implanted permanent Freedom System:

1. Remove the Transmitter Assembly (the external component of the system) and Wearable Accessory from the patient before allowing the patient to enter the MRI system room.
2. Do not conduct an MRI procedure if the patient has any other implant or health condition that prohibits or contraindicates an MRI examination. If the patient has another implant, especially an electronically activated or “active” device, the safety of performing an MRI with the addition of Freedom System (SCS/PNS) is unknown.
3.  Instruct the patient to immediately inform the MRI system operator (i.e., the MRI technologist) of any discomfort, stimulation, shocking, or heating, or other unusual sensation occurs during the examination.
4. The patient should be conscious during the MRI examination in order to inform the MRI system operator of any problem.
5. Verify with the MRI system operator that all proposed MRI conditions comply with the requirements specified in the Instructions for Use. If any MRI parameter is not met and cannot be modified, do not perform the MRI procedure.

As an MRI system operator, if you are unsure of your MRI system’s capabilities, contact the manufacturer. If the MRI scan sequences do not meet the conditions, then the pulse parameters must be adjusted so that they comply.

 

During an MRI Examination

The patient should be conscious during the MRI procedure to inform the MRI system operator of any discomfort, stimulation, shocking, or heating during the examination. Monitor the patient both visually and audibly. Check the patient between each MR imaging sequence. Discontinue the MRI examination immediately if the patient is unable to respond to questions or reports any problem.

 

Post-MRI Review

After the MRI procedure, verify that the patient feels normal.

After confirmation, remove the patient from the MRI system room and have the patient complete the following for the Freedom System (SCS/PNS):

1. Place the Transmitter Assembly in the Wearable Accessory and over the implanted stimulator.
2. Turn on stimulation by powering on the Transmitter Assembly and adjusting to identified Power Index.
3. Confirm proper stimulation and check that indicator lights are operating as expected.
4. Turn off the Transmitter Assembly if it is suspected that the external components (Transmitter Assembly) or internal stimulator is not functioning properly or if any discomfort, stimulation, shocking, or heating occurs.*

*If any of these event(s) occurs, turn off the Transmitter Assembly and contact your local Curonix representative.

 

Freedom Trial Stimulator Systems for SCS and PNS

The Freedom Trial Stimulators (FR4A-TRL-A0, FR4A-TRL-B0, FR8A-TRL-A0, FR8A-TRL-B0) are MR Unsafe due to the lack of fixation of the device during the trial period.

 

MRI Scan Conditions

For more information on the permanent Freedom Systems and MRI scan conditions, please see the MRI IFU.