FDA: MRI, Implanted Brain Devices May Not Mix
Health Care Workers Reminded to Ask Patients About Devices Before Scans
May 10, 2005 -- The FDA has issued a public health notification as a reminder that "serious injury or death can occur when patients with implanted neurological stimulators undergo MRI procedures."
Doctors and radiology personnel should ask patients before magnetic resonance imaging (MRI) scans if they have or used to have implanted neurological stimulators, says the FDA.
The FDA says it has received several reports of serious injury, including coma and permanent neurological impairment, in patients with implanted neurological stimulators who underwent MRI procedures.
The cause is likely due to heating of the electrodes at the end of the lead wires, resulting in injury to the surrounding tissue, says the FDA.
"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," says the notice.
Patients with neurological stimulators should be sure to talk to the doctor who implanted or monitors the device before having any MRI exam to find out whether it can be performed safely, says the FDA.
In cooperation with the patients, doctors should do the following:
- Carefully screen all patients for any implanted devices prior to performing an MRI procedure, even if the implanted device has been turned off.
- Question patients 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 device, consider consulting with the referring physician to discuss other imaging options. For some implanted neurological devices, certain MRI procedures cannot be performed.
- If an MRI procedure is to be performed on a patient with an implanted neurological device, be sure to review the labeling for the specific model that is implanted in the patient, with particular attention to warnings and precautions.
Hospitals and other facilities must report deaths or serious injuries associated with the use of medical devices, says the FDA's notice.