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  1. #1
    ICN Founder icnmgrjill's Avatar
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    FDA Safety Alert - May 10, 2005 - Complications with MRI

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    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 FDAs 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
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  2. #2
    ICN Member tigger_gal's Avatar
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    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
    'The will of God will never take you where the Grace of God will not protect you.'

  3. #3
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    I did receive a email from Medtronics today regarding medic braclets, however all my previous post about this are missing. I was trying to help all with Interstim receive help with this issue.

    Sorry!!

  4. #4
    ICN Member patricia1's Avatar
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    Stasny could they be on the other thread??? I thought I saw it posted twice...what did medtronics say about the bracelet
    God grant me the serinity to withstand the days ahead!!!

    My myspace link...
    www.myspace.com/patricia_luvs_matt


    Patricia

    In Memory of My Father (Lawerence) 1/25/2007

    Procedures:
    Interstim Sept 2001
    1st InterStim Removal May 2005
    2nd Interstim Implanted May 2005
    2nd InterStim Removed March 2007
    Hysterectomy 1999
    Tubes Tied 1997
    C-Section 1996


    Me and my kids


    Taylor (my daughter) Me and my daughter My son Cody and Taylor

  5. #5
    ICN Member tigger_gal's Avatar
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    Patricia,
    I looked all over the boards. the info/reply that stasny posted from imedtronics is gone...
    Brat
    'The will of God will never take you where the Grace of God will not protect you.'

  6. #6
    ICN Member patricia1's Avatar
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    I really dont understand why her post would go missing, she is only trying to help....Oh well, I do think that happened to her once before....Kinda of strange huh
    God grant me the serinity to withstand the days ahead!!!

    My myspace link...
    www.myspace.com/patricia_luvs_matt


    Patricia

    In Memory of My Father (Lawerence) 1/25/2007

    Procedures:
    Interstim Sept 2001
    1st InterStim Removal May 2005
    2nd Interstim Implanted May 2005
    2nd InterStim Removed March 2007
    Hysterectomy 1999
    Tubes Tied 1997
    C-Section 1996


    Me and my kids


    Taylor (my daughter) Me and my daughter My son Cody and Taylor

  7. #7
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    Bladder PaceMaker

    I have Chronic IC. DX in May 2004. Have tried different drugs none seems to work because my bladder is too small. Now my doctor wants to try as she calls it a bladder pacemaker, she says it is like a heart pacemaker and it has a magnet. Can anyone explain this to me or give me a website to this please. I asked her to explain she said she would tell me more later if that is the decision I make. But, I would like to know what it is.

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