User's Manual

Image Artifacts
MR image quality may be compromised if the area of interest is in the exact same area
or relatively close to the position of the StimRouter lead. Therefore, optimization of MR
imaging parameters to compensate for the presence of the StimRouter lead may be
necessary.
Induced Currents
The electric fields induced in the patient with the StimRouter lead by the pulsed gradient fields
were calculated. The induced current will be less than the stimulation threshold if the StimRouter
lead is at least 50 cm from the center of the bore and at least 16 cm outside of the MR coil
measured from the edge of the MR coil.
Potential Adverse Events
Use of MRI could result in excessive heating of the lead if the MRI conditions of use are not
followed. Induced voltages in the lead may occur, possibly causing uncomfortable levels
of neurostimulation.
Note: The StimRouter lead is not a life-sustaining device and could be explanted prior to an
MRI procedure.
Pregnancy
The effects of electrical stimulation on pregnancy are unknown. Patients should avoid exposure
to electrical stimulation for the entire duration of pregnancy.
Long-Term Effectiveness of Neurostimulation
The long-term effectiveness of neurostimulation is unknown.
Programming
The StimRouter components should only be programmed by the treating clinician and/or under
proper medical guidance.
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Clinician’s Guide