Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series.

OBJECTIVE

Advances in spinal cord stimulator (SCS) technology and increasing prevalence of magnetic resonance imaging (MRI) diagnostic testing require empirical evidence describing the presence of MRI-related SCS adverse events related to off-label use of imaging. MRI safety recommendations vary based on the type of stimulator used with scant availability regarding adverse events associated with off-label MRI use. The aim of this case series is to describe the type and frequency of adverse events associated with off-label MRI use in patients with implanted SCSs.

MATERIALS AND METHODS

Convenient samples of records of patients who had SCS and subsequently underwent MRI were included. Descriptive data including patient demographics, stimulator information, and frequency of adverse events were described.

RESULTS

Sixty-nine individuals with implanted SCSs were included. The total number of scans was 78. Sixty-two percent of the sample was female. Over 92% of the MRI scans were considered off-label and the overall adverse event rate for off-label use was 9.72%. No serious adverse events were reported. Seven clinical adverse events were reported, all of which were related to the spinal cord stimulation and resolved.

CONCLUSION

This case series demonstrates that individuals implanted with SCSs experienced no serious adverse events associated with off-label MRI use. While these results represent a convenient sample, they provide important preliminary information about using MRI when medically necessary for patients with older spinal cord stimulator models. Specifically, these data demonstrate that the rate of observed adverse events related to MRI was low and suggest that the benefits of acquiring these images for pain management may outweigh the risks of not acquiring MRI for appropriate pain management.