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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. 

Models:
PrimeAdvanced SureScan MRI, Model 97702
RestoreUltra SureScan MRI, Model 91112
RestoreAdvanced SureScan MRI, Model 97713
RestoreSensor SureScan MRI, Model 97714

Important note: Each device indicated above is a “full-body eligible system” if all specific MRI conditions and device requirements are carefully followed.

The Medtronic neurostimulation systems used for spinal cord stimulation with SureScan MRI Technology have been specially designed to minimize the potential interactions associated with MRI. These specific spinal cord stimulation systems allow patients safe access to an MRI scan anywhere in the body, referred to as “full-body eligible”.

For Medtronic spinal cord neurostimulation systems with SureScan MRI Technology, external control devices (i.e. a clinician programmer or a patient control device) are used to determine MRI scan-type eligibility and are used to place the neurostimulation system in an MRI conditionally safe (MRI-CS) mode (also referred to as "MRI mode"), which turns stimulation off.

If the clinician programmer or a patient control device cannot communicate with the implanted neurostimulation system or if the neurostimulator has reached EOS (end of service), then MRI conditional safety cannot be confirmed via the external control devices. Researching the implanted neurostimulation system configuration from the patient's medical records is required. Unless the implanted system configuration is known and it is determined to be safe to perform an MRI under specific conditions, an MRI scan should not be conducted.

Additional conditions apply to ensure safety for patients with spinal cord stimulation systems that have SureScan MRI Technology must be reviewed to ensure patient safety. Please refer to: www.medtronic.com/mri

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]

REFERENCES

www.medtronic.com

www.medtronic/mri

 



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