FDA Public Health Notification: MRI-Caused Injuries in Patients with
Implanted Neurological Stimulators

(You are encouraged to copy and distribute this information)

Issued: May 10, 2005

This is to remind radiology personnel and physicians that serious injury or
death can occur when patients with implanted neurological stimulators
undergo MRI procedures, and to recommend preventive actions.

Background

The FDA 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.

Recommendations

If you are a physician who implants or monitors patients with implanted
neurological stimulators:

Explain to the patient what MRI procedures are and stress that they must
consult with the monitoring physician before having any MRI exam to find out
whether it can be performed safely.
If you are a radiologist or health care professional who uses MRI equipment:

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. Also 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 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. The radiologist may need to consult with the
implanting or monitoring physician for this information. Also note and
follow any instructions exactly for MRI imaging that may be in the labeling
for the implant, including information on types and/or strengths of MRI
equipment that may have been tested for interaction with the particular
implanted device. The radiologist may need to consult with the device
implant manufacturer for this information.
Reporting Adverse Events

FDA requires hospitals and other user facilities to report deaths and
serious injuries associated with the use of medical devices. If you suspect
that a reportable adverse event has occurred involving a patient with an
implanted device who has undergone an MRI procedure, you should follow the
reporting procedure established by your facility.

We also encourage you to report adverse events related to MRI and medical
devices that do not meet the requirements for mandatory reporting. You can
report these directly to the device manufacturer. You can also report these
events to MedWatch, the FDA's voluntary reporting program. You may submit
reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by
mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857-9787; or online at
http://www.fda.gov/medwatch/report.htm.

Getting More Information

If you have questions about this notification, please contact Nancy Pressly,
Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive,
Rockville, Maryland, 20850, Fax at 301-594-2968, or by e-mail at
phann@cdrh.fda.gov. You may also leave a voice mail message at 301-594-0650
and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet
at http://www.fda.gov/cdrh/safety.html. You can also be notified through
email on the day the safety notification is released by subscribing to our
list server. To subscribe, visit:
http://list.nih.gov/archives/dev-alert.html.

Sincerely yours,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration

Updated May 10, 2005

http://www.fda.gov/cdrh/safety/neurostim.html