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Author Topic: FDA Alert re CT Scans & Implanted Medical Devices  (Read 25507 times)
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gel61820
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« on: July 14, 2008, 12:06:35 PM »

[span style=\'font-size:14pt;line-height:100%\']FDA Preliminary1 Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning

Date July 14, 2008

Dear Healthcare Professional:

This is to alert you to the possibility that the x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction, and to provide recommendations to reduce the potential risk.


Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, FDA has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. There have been similar reports in the literature.2-4

It is possible that this interference is being reported more frequently now because of the increased utilization of CT, the higher dose-rate capability of newer CT machines, an increase in the number of patients with implanted and externally worn electronic medical devices, and better reporting systems.

We are continuing to investigate this issue while working with device manufacturers and raising awareness in the healthcare community. To date, no patient deaths have been reported from CT scanning of implanted or externally worn electronic medical devices.

Adverse events
In the reports received by FDA, the following adverse events were likely to have been caused by x-rays from CT scans:

Unintended
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« Reply #1 on: July 14, 2008, 12:19:08 PM »

OMG!

I am moving this to an open forum so EVERYONE can be made aware!
« Last Edit: July 14, 2008, 02:31:33 PM by Birdbomb » Logged

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gel61820
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« Reply #2 on: July 14, 2008, 12:35:01 PM »

:Censored:

Quote
Experimental studies with anthropomorphic phantoms have demonstrated the potential for high dose rate CT irradiation to affect implanted cardiac rhythm management devices.3,4 Some occurrences in patients, which involved neurostimulator and pacemaker devices, have also been reported to FDA and appear in the literature.3,5
[/color][/b]

This makes me sick!  What does it take for the FDA to realize that Cyberonics and other medical device manufacturers need to be held accountable for problems that these devices cause?  It is one thing to think that you cannot have an MRI but to take the chance of "unintended shocks" by having a CT scan puts our lives at risk if we are in need of medical results.

I would love to get my hands on the literature that they are referring to in the above quote.  I have already sent this FDA alert to my neuro's office and will be talking with my new neuro-optho on Wed about it.  

Hugs,
Cindy




 
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"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
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« Reply #3 on: July 16, 2008, 11:12:37 AM »

Additional FDA Update on CT Scans & Implanted Medical Devices

Here is the newest FDA update on this issue.
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"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
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« Reply #4 on: July 24, 2008, 07:42:35 AM »

THANK YOU SO MUCH! I JUST had a cat scan 2 days ago! It was for my lower back I now have sciatica (woo hoo) I didn't even THINK to turn it off for the test! My goodness! THANK YOU THANK YOU!
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« Reply #5 on: July 28, 2008, 07:19:15 AM »

<a href="http://www.youtube.com/watch?v=VMeELviGqic" target="_blank">http://www.youtube.com/watch?v=VMeELviGqic</a>

Quote
FDA recently issued a notification to health care professionals which warned about the possibility of serious injury if patients with implanted neurological stimulators undergo MRI exams. The injuries reported to FDA have included coma and permanent neurological damage. They were likely caused by heating of the electrodes at the tip of the leads.

Neurological stimulators include a fairly wide variety of products i.e., neuromuscular stimulators, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators and peripheral nerve stimulators.

Physicians who either implant these stimulators or monitor patients who have them should warn patients that if an MRI procedure was prescribed, they should check back with the monitoring physician and make sure it can be performed safely.

In addition, radiology personnel should screen patients for the presence of implants before performing an MRI exam. It's important to ask about both present and past implants. That's because sometimes when an implant is removed, the pulse generator is explanted but the leads remain in place in the patient. These leads can be heated by the MRI and cause a problem as well.

If the patient does have an implanted neurological stimulator, then consider consulting with the referring physician about other imaging options. If it's decided that an MRI procedure is indicated, be sure to review the labeling for the specific model stimulator, and pay particular attention to warnings and precautions. For some stimulators, the labeling may specify the types or strengths of MRI equipment that can be used. But with other stimulators, certain MRI procedures simply can't be performed.
« Last Edit: January 05, 2011, 09:27:45 AM by Birdbomb » Logged

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Electrodes are in me for LIFE!
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« Reply #6 on: October 01, 2008, 01:40:07 PM »

Here is a link to a video on the FDA alert on CT Scanning.  Scroll part way down the page to "CT Scanning May Cause Malfunction of Electronic Medical Devices" and then on the right you can play this via MediaPlayer or RealPlayer, or you can read the material that is being sent to the medical professionals on how to deal with CT Scans for those with implanted medical devices.

FDA MedWatch - Patient Safety News Video - October 2008
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"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
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« Reply #7 on: October 10, 2010, 11:12:57 PM »

There is something that I just found that I think is very important and all of you with ANY implanted device should read this.

At  http:/www.softwarefreedom.org/resources/2010/transparent-medical-devices.html is an article which is called: 'KILLED BY CODE: SOFTWARE TRANSPARENCY IN IMPLANTABLE MEDICAL DEVICES' This article is a little scary. It talks about while there is yet to be a documented incident in which the source code of a medical device was breached for malicious purposes, in 2008 there was a study led by software engineer and security expert Kevin Fu in which he proved that it IS possible to interfere with an ICD that has passed FDA's approval process and been implanted in hundreds of thousands of patients. Not only were these researchers able to first DISABLE the devices, but then they were able to deliver multiple shocks averging 137.7 volts that would induce ventricular fibrillation in a patient.

He shows in this article that almost anyone can build a device with easily store-bought ingredients that could then send out heart attack commands to thousands of people in malls, subways, anywhere. This is a direct quote from this article: 'THOUGH THE ADVERSIAL CONDITIONS DEMONSTRATED IN FU's STUDIES WERE HYPOTHETICAL, 2 EARLY INCIDENTS OF MALICIOUS HACKING UNDERSCORE THE NEED TO ADDRESS THE THREAT OF SOFTWARE LIABILITIES POSE TO THE SECURITY OF IMD's.

IN NOVEMBER OF 2007, a group of attackers infiltrated the COPING WITH EPILEPSY website and planted flashing computer animations that triggered migraine headaches and seizures in photo-sensitive site visitors. A year later the did the same thing on the EPILEPSY FOUNDATION WEBSITE.
« Last Edit: January 24, 2011, 06:14:05 AM by Birdbomb » Logged
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« Reply #8 on: October 24, 2010, 05:54:05 AM »

 Shocked Wow Ms. Nancy, THNX for the info!

Take care!
Cool
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« Reply #9 on: January 24, 2011, 05:38:37 AM »

 angry angry angry Undecided  Hello ever one. Today is Monday January 24th, 2011. Tomorrow I will have a biopsy done on a very fast growing lump with different colors and uneven edges, it has grown in 6 months from a little unoffensive node. This lump also has a cousin on the same side of my body this bump sits directly on my left collar bone where that bone attaches to my shoulder I called my neurologists' office this am to double check about scans I can and cannot have. Scanning has changed so much. Maybe I am just an ODF but I thought an MA and a PA was suppose to be an informed professional I could get answers from. Evidently I am the ODF. I will have to get answers the old fashioned way: nurse to nurse then doc to doc then to me, that could only take a week, if it don't snow, and the wind don't blow. I like things done efficiently because I am the person that will makes the decision as to how and what the treatment will be after the biopsy. Feed back?
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« Reply #10 on: January 24, 2011, 06:50:05 AM »

suspender
According to Cyberonic$

Quote
MAGNETIC RESONANCE IMAGING (MRI) ______
Caution: Magnetic resonance imaging (MRI) should not be
performed with a magnetic resonance body coil in the transmit
mode. The heat induced in the Lead by an MRI body scan can cause
injury.
If an MRI should be done, use only a transmit and receive type of
head coil. Magnetic and RF fields produced by MRI may change the
Pulse Generator settings (change to reset parameters) or activate the
device. Stimulation has been shown to cause the adverse events
reported in the “Adverse Events” section in the indication-specific
parts of the multi-part physician manuals. MRI compatibility was
demonstrated using a 1.5T General Electric Signa Imager with a
Model 100 Pulse Generator and 300 Lead only. Model 101, 102,
102R, 103, and 104 Pulse Generators are functionally equivalent to
the Model 100. Model 302, 303, and 304 Leads are functionally
equivalent to the Model 300. Testing on this imager as performed on
a phantom1
 indicated that the following Pulse Generator and MRI
procedures can be used safely without adverse events:
„ Pulse Generator output programmed to 0 mA for the MRI
procedure, and afterward, retested by performing the System
Diagnostics (Lead Test) and reprogrammed to the original
settings
„ Head coil type: transmit and receive only
„ Static magnetic field strength: ≤2.0 tesla
„ Specific absorption rate (SAR): <1.3 W/kg for a 154.5-lb (70-
kg) patient
„ Time-varying intensity: <10 tesla/sec
Use caution when other MRI systems are used, since adverse events may
occur because of different magnetic field distributions. Consider other
imaging modalities when appropriate.
Caution: Procedures in which the RF is transmitted by a body coil
should not be done on a patient who has the VNS Therapy™
System. Thus, protocols must not be used that utilize local coils that
are RF-receive only, with RF-transmit performed by the body coil.
Note that some RF head coils are receive-only, and that most other
local coils, such as knee and spinal coils, are also RF receive-only.
These coils must not be used in patients with the VNS Therapy
System.

[copied as written in the Physician's Manual]

According to the FDA

Quote
FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and magnetic fields.

Most patients with electronic medical devices do not experience problems with CT scans, but FDA has received a small number of reports in which the scans may have caused unintended shocks from neurostimulators, malfunctions of insulin pumps, and transient changes in pacemaker output. Theoretically, defibrillators, cochlear implants and retinal implants could also be affected.

Here is what FDA recommends to help reduce any possible risk:

• Before beginning a CT scan, use scout views to check whether the patient has an electronic medical device and where it is. If the device is in or very near the area to be scanned, there are several steps to take.

• Determine the device type. If it is an externally worn device, try to move it out of the scan range, if possible. If it is a neurostimulator, ask the patient to temporarily shut it off.

• During the scan, minimize x-ray exposure to the device by using the lowest x-ray tube current that will allow you to get the required image, and by making sure that the x-ray beam does not dwell over the device for more than a few seconds. If the procedure requires continuous scanning over the device for longer than that, as with CT perfusion or interventional exams, be ready to take emergency measures to treat adverse reactions if they occur.

• After the scan, remind the patient to turn the device back on if it was turned off beforehand. Even if the device was turned off during the scan, ask the patient to be sure that it is working properly. If not, tell the patient to contact their healthcare provider as soon as possible.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=80#2

I had a few CT scans before this warning was made public, and never experienced any problems.  My generator has been remove , but the electrodes are still on my vagus nerve and now can't even get an MRI in Las Vegas.  I've spoken to several Radiologist and they all refuse the MRI stating the coils of the electrodes heat up, causing coma or brain death.  This delightful problem is NOT posted anywhere on the Cyberonic$ site.

Even IF your hospital as the "General Electric Signa Imager", there is no way of knowing if it has been properly serviced. GE has had a very poor record of service for several years.

You can only do the best you can.  SEARCH the net for as much info as you can find.  Discuss this with your doctors AND the radiologists.
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VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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« Reply #11 on: January 24, 2011, 10:49:57 PM »

 Smiley HI suspender!

Crossing my fingers and toes all turns up well with these lumps and such.

I had an MRI done on my head while I was implanted with VNS.  The device was shut off at the docs office for that one, and the radiology folks used a head coil send and receive unit/guard over my entire head--it covered my upper chest and whole head.  I also had a CT done too and no issues.  I also had a nerve conduction study done, and my device was shut off with the magnet for that.  I don't think that one was a good thing to have because it was done all along my left side, and I didn't feel very well after that ordeal.  Plus, my magnet casing was cracked after that, and nothing other than the nerve conduction study happened to crack it.

Now that I've had total explant, radiology folks don't want to do anything with me in regards to MRI's and CT's without the x-ray confirmation that all my coils and wires are gone.  In my case, during explant the lead wires broke into pieces when the surgeon touched them, so he had to fish around for the lil pieces, but, it's all out.

Please do keep in touch and be well!

Cool
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VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
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« Reply #12 on: February 09, 2015, 11:46:10 AM »

THANK YOU SO MUCH! I JUST had a cat scan 2 days ago! It was for my lower back I now have sciatica (woo hoo) I didn't even THINK to turn it off for the test! My goodness! THANK YOU THANK YOU!

they do not need to turn it off for that type of test because your lower back is not in the vicinity of any disruption. I experienced nothing when going through an updated CT Scan because I have been in a severe car accident that destroyed my lower back including gave me nerve damage. I needed to have the CT Scan done and there was no reasoning for the VNS to be turned off at the time because it was only an X-ray not magnetic imaging like an MRI is.

MRI's are completely different in comparison to CT Scans and any doctor will tell you that information if you ask them. I have been through this matter many times over the years and am providing the same information I have been given by medical professionals.
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« Reply #13 on: February 11, 2015, 04:47:43 AM »

CT and MRI's were a different story 10 years ago.  Every radiologist I have dealt with since then are fairly educated about neuromodulators now. Vegas especially since a woman was killed during a MRI 9-10 years ago.  Can't get an MRI now even with only the electrodes left in.
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"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
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