MRI safety information
NOTE: This information is for patients who have confirmed with SPR that they have MicroLead 1.0. If you have MicroLead 2.0, please use the information on this page. If you are unsure, call SPR at 844-378-9108.
The SPRINT® PNS System is MR Unsafe – All MRI procedures, no matter the anatomic site, are contraindicated for patients with the SPRINT® PNS System. Exposure can cause tissue heating and injury or unwanted stimulation. Pull out the Lead and remove all other System components from the patient before an MRI examination is performed.
In the case of a Lead fracture beneath the skin resulting in a retained lead remnant, an MRI examination is safe to perform under the conditions described in the MR Conditional statement below.
A retained Lead Remnant ONLY is MR Conditional
Non-clinical testing has demonstrated that a Retained Lead Remnant ONLY is MR Conditional. A patient with a retained remnant can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla
- Maximum spatial field gradient of 2,000 gauss/cm (20 T/m)
- Maximum MR system reported whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the Retained Lead Remnant is expected to produce a maximum temperature rise of less than 3.3°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by a Retained Lead Remnant extends less than 7mm from the remnant when imaged using a gradient echo pulse sequence and a 1.5 T MRI system.
NOTE: There should be no section of Lead visible above the skin.
NOTE: If a Lead is placed in an individual with an existing retained Lead remnant, the new Lead should not be placed in a location where it could touch the original Lead remnant. During MRI, two Lead remnants touching each other can result in an increase in temperature of the Lead remnants and surrounding tissue where they touch.
