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U.S. Department of Health and Human Services

Safety

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MRI-Caused Injuries in Patients with Implanted Neurological Stimulators

Audience: Radiology personnel, neurosurgeons, and hospital risk managers

FDA notified healthcare professionals that serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures. The FDA received several reports of serious injury, including coma and permanent neurological impairment. 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. The public health notification also offered recommendations for preventive actions.

[May 10, 2005 - Public Health Notification - FDA]