Serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures.

The FDA ( Food and Drug Administration ) has received several reports of serious injury, including coma and permanent neurological impairment, in patients with implanted neurological stimulators who underwent magnetic resonance imaging ( MRI ) procedures.

The mechanism for these adverse events is likely to involve heating of the electrodes at the end of the leadwires, resulting in injury to the surrounding tissue.

Although these reports involved deep brain stimulators and vagus nerve stimulators, similar injuries could be caused by any type of implanted neurological stimulator, such as spinal cord stimulators, peripheral nerve stimulators, and neuromuscular stimulators.

All patients should be carefully screened for any implanted devices prior to performing an MRI procedure, even if the implanted device has been turned off.
Patients should inform physicians about previously implanted devices that have been removed. Leads, or portions of leads, often remain in the body after pulse generators are removed, and these may act as an antenna and become heated.

If the patient does have an implanted neurological stimulator, consider consulting with the referring physician to discuss other imaging options.

For some implanted neurological stimulators, certain MRI procedures are contraindicated and cannot be performed.

If an MRI procedure is to be performed on a patient with an implanted neurological stimulator, be sure to review the labeling for the specific model that is implanted in the patient, with particular attention to warnings and precautions.

Source: FDA, 2005


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