Magnetic resonance imaging (MRI) may be safely performed under certain conditions on a patient with a Freedom Stimulator, however, the Wearable Antenna Assembly (WAA) unit (i.e., the external component of this neuromodulation system) MUST NOT be present in the MR 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.
The following steps must be performed prior to an MRI on a patient with an implanted Freedom Stimulator:
Non-clinical testing has demonstrated the Freedom-8A SCS Stimulator Receiver is MR Conditional. The Freedom-8A Stimulator Receiver can be scanned safely under the following conditions.
NOTE: Enter the patient’s weight into the MR system console to ensure that the whole body averaged specific absorption rate (SAR) is estimated correctly.
Non-clinical testing has demonstrated the Freedom-4 SCS Stimulator is MR Conditional. The Freedom-4 Stimulator can be scanned safely under the following conditions.
NOTE: Enter the patient’s weight into the MR system console to ensure that the whole body averaged specific absorption rate (SAR) is estimated correctly.
Non-clinical testing demonstrated that the Freedom-4A (StimQ) Stimulator/Spare Lead with Receiver/RF Stylet is MR Conditional. A patient with this device can be safety scanned in an MR system meeting the following conditions.
NOTE: Enter the patient’s weight into the MR system console to ensure that the whole body averaged specific absorption rate (SAR) is estimated correctly.
The Freedom-4A SCS System is MR Unsafe. Since the Freedom-4A SCS System is MR Unsafe, the strong magnetic field of the MR system could attract or otherwise damage the System, and in the process cause serious harm to the patient or other people or damage to the MR system.
The Freedom-8A PNS System is MR Unsafe. Since the Freedom-8A PNS System is MR Unsafe, the strong magnetic field of the MR system could attract or otherwise damage the System, and in the process cause serious harm to the patient or other people or damage to the MR system.
The patient should be conscious during the MRI procedure. 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.