The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators. The statement from the FDA can be found here.
Tag: medtronic
Medtronic ICD Recall
The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators. The statement from the FDA can be found here.
The recall impacts Medtronic’s Evera and Visia brands of ICDs as well as its Viva, Brava, Claria, Amplia and Compia brands of cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from August 31, 2012 to May 9, 2018. The problem is described as “an unexpected and rapid decrease in battery life” caused by a short circuit. The defect may cause devices to go from recommended replacement time (when your alarm sounds to notify you that it is time to schedule a replacement surgery) to full battery depletion in just one day. Normally, you would have approximately 3 months from the time that the alarm first sounds to schedule a procedure to implant a replacement.
According to this article, there have been 444 complaints and 264 medical device reports about this issue which impacts 239,171 devices.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device. If this particular recall affects your device, you will see the same advisory which is circled in red in the photo below.
Patients are advised to continue routine follow ups and use the Care Link Monitoring System.
And, as always, you can call Medtronic Patient Services with any questions at: (800) 551-5544
(M – F, 8am – 5pm Central).
Reporting Issue with 50,000 Medtronic Fidelis ICD Leads
According to a story broken by Kaiser Health News this week, due to a reporting waiver granted to Medtronic by the FDA, as many as 50,000 problems with the Medtronic Fidelis lead were not reported to the FDA. Ordinarily, the FDA uses its MAUDE database to collect reports of adverse events in medical devices. In these cases, the MAUDE database was circumvented.
Medtronic responded by saying that instead of using MAUDE, they disclosed the issues in summary fashion to the FDA, as well as reporting them to physicians and to the public.
The following stories provide additional details about this controversy:
Hackers and ICDs: What to Know About Today’s Medtronic Warning
Today, it was announced by the U.S. Department of Homeland Security that 750,000 implantable defibrillators manufactured by Medtronic could potentially be vulnerable to hacking.
Continue reading “Hackers and ICDs: What to Know About Today’s Medtronic Warning”
Guest Blogger Doug Rachac – Magnets and Airports: Should ICD Patients Be Afraid?
Editor’s Note: Doug Rachac found out that he himself needed an ICD while employed by device manufacturer Medtronic. He now uses his personal experiences to help other device patients learn how to live happily with their implantable devices.
When cardiac patients receive a pacemaker or defibrillator, they often have questions about their new “friend.” They wonder if this new device has limitations, and what those limitations might be.
And they may find that the internet can be, at the same time, both helpful and misleading. Accurate information is out there, but separating truth from fiction is the hard part. To learn the truth, patients turn to their doctors, nurses and clinic device techs for answers, not realizing that sometimes these professionals also give advice based on outdated or incorrect information.
When a patient wants to know if it is safe to scuba dive with their heart condition, they should ask their physician. However, if they want to know how deep it is safe for them to dive with their specific implanted device, instead of asking their physician, they should instead direct their question to the engineers of the device manufacturer who designed and tested the device.
Patients should speak with their doctor to learn if their health condition limits them from certain physical activities (such as scuba diving), but questions about the limitations or capabilities of devices and leads should usually first be directed to the manufacturer of the device – the best source of up-to-date, accurate information. Whenever I am looking for up to date, accurate information about my device, I start with Medtronic, the manufacturer of my implanted device.
Patients can easily find the make and model of their device, as well as learn how to contact their device manufacturer, by calling the Patient Services number located on their Patient ID card.
In this blog article, I’d like to share with you some information regarding two of the most common misconceptions relating to implantable devices out there: 1) magnets are dangerous to implanted devices like pacemakers and defibrillators; and 2) it is unsafe to walk through airport/venue security.
All of the information I discuss below can be found, if you dig deep enough, on each specific manufacturer’s websites.
Magnets: Should We Be Afraid?
All companies advise patients to keep magnets at least 6-8 inches away from their devices for their safety. But the simple answer to the question is NO! You do not need to be afraid of magnets. However, you do need to be aware of how a magnet interacts with your device when you come into contact with one.
A magnet will NOT:
- Scramble the device programming
- Turn the device off
- Turn off pacing
- Damage the device in any way
These common misconceptions are based on devices that are over 10 years old, or are based on a misunderstanding of the truth. In most industry devices a magnet will interact with a pacemaker and defibrillator in the following ways:
Pacemaker or Cardiac Resynchronization Therapy Pacemaker (CRT-P):
A magnet placed on or near a pacemaker/CRT-P device will force the device to pace at a constant, preset rate. Different companies have different preset rates. Medtronic is set to pace 100% of the time at 85 beats per minute (BPM). When the magnet is moved away from the device, the device will immediately revert back to the programming that was input by the doctor or device tech at implant, or that was modified during a subsequent interrogation session.
Defibrillator or Cardiac Resynchronization Therapy Defibrillator (CRT-D):
In most industry devices, a magnet will “inhibit detection” which is a fancy way of saying the device won’t shock you if needed. Once the magnet is removed, the shock function reverts back to normal.
This function is a normal design feature of the devices designed for use by clinicians and doctors. In both types of devices, a magnet will in no way harm the device or alter the programming. The effect of the magnet is only temporary. Once the magnet is moved 6-8 inches away from the device, the device’s normal programming will resume. Some everyday items such as iPad covers, purses, and children’s toys may contain magnets which are strong enough to trigger the magnet response in our devices. However, simply moving those items 6-8 inches away from your device will resolve the issue. Remember, even if you do encounter a strong magnet or magnetic field, it will not harm your device in any way. Simply move away from the magnet/magnetic field and your device will return to its normal operations.
Let me reiterate: a magnet will in no way harm your device, shut it off, or alter the programming.
Airport/Venue Security:
There was a time when walking through airport or venue security with an implanted device was considered dangerous. This was back when our devices included an electrical component called a Reed Switch. But, over a decade ago, devices evolved after safety issues forced industry to eliminate the Reed Switch in all implanted devices. At the same time, a new international standard emerged setting limits for how much magnetic energy an implanted device needed to be able to withstand. The level is high enough that most forms of magnetic energy encountered in our daily lives are insufficient to interact with our devices in any meaningful way. There are a few exceptions, such as the electromagnetic energy generated by a hydroelectric dam. But, airport archways and hand wands do not generate that level of energy. Companies like Medtronic simply suggest that a patient walk through the airport archway at a normal pace, and that wands are not waved repeatedly over the device multiple times. Aside from those precautions, patients do not need to avoid airport or venue security in any way. Millimeter wave scanners (the one that rotates around you) are also safe to use.
Let me say it again: Pacemaker/ICD/CRT patients do not need to fear airport/venue security checkpoints. Simply walk through the archway at a normal pace, and ask that wands not be waved back and forth over the device repeatedly.
Living with our devices can be stressful enough. It’s my belief that having accurate information is the first step in being able to live the life we want to live, not the life we think we are now forced to live.
My physician was clear when he said, “Your device is there to protect you and allow you to live your life. It is not there to restrict you in any way.”
It’s time to dispel the information of old, and to start living our lives without these old fears. Our devices have evolved over the years so we need not fear magnets or security lines any more. If you would like to learn more about me and living with an implantable device, I have uploaded several videos to my YouTube Channel. You can find specifically about devices, magnetic fields and airport security here.
About Doug Rachac:
Doug Rachac received his implanted Medtronic defibrillator in 2014 due to several episodes of syncope and documented non-sustained ventricular tachycardia. He spent 14 years working for Medtronic, where he worked in multiple areas, including Customer Service, Education, and Quality. He left Medtronic in 2015 to recover, volunteer and to be the world’s best stay-at-home dad. He now advocates for device patients and consults with the medical device industry on patient engagement and patient focused initiatives. You can find him on Twitter @HankEPants.
Medtronic ICD Advisory Expanded
The January recall of 48 Medtronic CRT-D and ICDs has now been expanded to include 752 additional devices at lower risk than those involved in the January recall,. There is an issue that occurred during the manufacturing process of these devices which could result in an unexpected loss of device functionality. If you have one of these devices, you should contact your doctor to discuss next steps.
You can see the advisory here.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device.
If you are affected, the search page would look like this:
This example shows that currently there are no advisories for my model.
As always, you can call Medtronic Patient Services with any questions at: (800) 551-5544 (M – F, 8am – 5pm Central)
Limited Recall of Medtronic ICDs and CRT Devices
Medtronic has recalled a small number of ICDs and CRT-D devices. A total of 48 devices implanted in patients may contain a manufacturing defect which would prevent the device from delivering an appropriate shock if needed.
This is a Class I recall, which is the most serious as determined by the FDA.
Physicians of record of those affected by the recall should have already been notified by Medtronic.
You can find a list of affected devices and serial numbers here.
You can also contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
Yes We Scan! ICDs and MRIs
Why MRI is Important:
Magnetic Resonance Imaging, or MRI, is one of the most important tools of modern medicine. MRIs can be used to evaluate almost every kind of medical issue, from brain tumors to twisted ankles. They provide clear images, and in some instances, also provide superior visualization. Because they do not expose the imaging subject to radiation, they are generally preferred over CT scans, even when the two scans would reveal the same information.
MRI in HCM:
In the last several years, MRI has also become an important tool in the evaluation of hypertrophic cardiomyopathy (HCM). The images resulting from MRI have proven superior in visualizing the size and structure of the heart and, when used with a contrast agent, MRIs are able to show the extent of scarring in the HCM heart.
MRI Hasn’t Been an Option for Many of Us:
MRI has been unavailable to those of us who have an implantable defibrillator or ICD to in order to protect us from sudden cardiac arrest. Until recently, having an ICD was an absolute contraindication to MRI. Newer MRI-safe ICD systems have been in use for the last few years, but that still leaves in place the contraindication for those of us who have older ICD units in place. That problem is that older lead systems that were implanted along with old, non-MR compatible generators may be incompatible with the newer MR compatible technology, and it may not be possible to simply hook up these old leads to a new MRI compatible generator. And, it is not as easy as you might think to extract old leads. Scar tissue grows around these leads, making their removal an intricate and dangerous procedure that is best done only in carefully controlled circumstances by highly specialized physicians. Continue reading “Yes We Scan! ICDs and MRIs”
HCM Beat 