FDA Safety Alert - May 10, 2005 - Neurostimulation & MRI

[icnmgrjill]

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

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

(1) 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.

(2) 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

[tigger_gal]

One of the first things I was told that I would never be able to have an MRI once I had the interstim put in.. I was told this by my Urologist. You have to carefull consider this, because many or dx'ed are thru an mri.. It is very important that this is told to you by your dr and by Medtronics, Whech they indeed told me and asked if it was understood...

I am going to get me a med alert bracelet that indicates I have the interstim, incase in the unlikely event something happens to me and I am un-consious, and have no one with me... I think thats a good Idea for any one who has the interstim or any type of implanted device to get one ... Matter of fact I think it should be part of any type of implantion procdure to be given a med alert bracelet.
Brat

[angelaharrell]

You know, I was never informed by my urologist about MRI's. I read it in my handbook. Thank goodness I read! I also wasn't aware until recently that I was suppose to premedicate for dental appointments due to the interstim. Geez, and I thought there wasn't enough info out there on IC-what about the lack of info on the interstim!!!!!

[Snuph]

Hi Angela,
I am interested why you are premedicating before dental appointments? I have never read that you need to do that?

[ICNDonna]

Any time anybody has an implant in the body, such as a pacemaker, pain pump, heart valve, interstim --- it can require antibiotics before dental work. There can be a lot of bacteria released in the system when having dental work and it's a precaution. My husband has a valve replacement and has to take antibiotics before his dentist visits.

Donna

[angelaharrell]

There is an excerpt in the handbook that talks about premed. I contacted Medtronic & they referred me back to the physician that did the interstim. She said "just to be on the safeside" I take 4 tablets 500mgs of an antibiotic 1 hour prior to my appointment. ICNDonna hit the nail on the head with her post. I use to work in a dental office and people with pacemakers had to premed. It got me to thinking so I referred to my handbook and there it was.

[patricia1]

Unfort. there is still alot of info not passed on to patients at the time of implantation or the trials. What I learned and what happened to me, came from me, not my urologist. That is why I love these threads so that we can pass our experiences on to each other. Sometimes it is the only way we will learn something. I have had mine since 2001 and revision done this past May and had NO IDEA what so ever of the dental thing. Thanks.

[tigger_gal]

HHHHHMMMMM.. thats one I didn't know.... I have had 2 teeh pulled since interstim... with out any complications. One was absesed. I"ll have to look into that one, because I will be having 4 to 6 more pulleed to get a partical on the top and bottom...
My Dentist knows I have the interstim, and he is actually informed on it, but, I didn't know about the premed thing.. Thanks

[Snuph]

There are no warnings on the medtronic interstim site about needing anything before dental work. I really think you need to talk this over with your dentist. Not all implants need antibiotic protection for dental work. What I have been told is that it depends on the materials used in the implant and the location of the implant.

[angelaharrell]

It refers to premedicating in the handbook issued by medtronic at the time of the interstim placement. Oh, and my Dentist prescriped the antibiotic as a precaution.

[bigred]

You found this information in your manual. I never heard of that. I know I had to be patted down at the airport. A whole lot of fun

[dancemomof2]

Can't find that in my manual anywhere. I have looked and looked at it.

[angelaharrell]

I have the Interstim Therapy Patient Manual dated 1999 and on page 37 it refers to premed. It says and I quote "Always tell your Medical and Dental personnel that you have an implanted Interstim System and present your Interstim identificatoin card so they can take proper precautions. For example you may be given a prescription for antibiotics prior to or following a medical or dental procedure to reduce the risk of infection of your implanted system".

The book also goes into detail about Ultrasound, Diathermy, MRI's, Pacemakers, & Heart Defibulators on pages 38 & 39.

If this topic isn't covered in everyones manual, this is not good!

[bigred]

Where did you get an inter-stiim book. I never got one with my inter-stim. I guess I cold try getting one from med-tronics.

[angelaharrell]

It was given to me at the time that the implant was surgically placed. It was in a box that contained two magnets to use in an emergency.