Now that the stock market is booming, people with pacemakers and some money to invest may wonder about investment opportunities with pacemakers. There are five companies that make pacemakers and defibrillators in the world: Medtronic, St. Jude Medical, Boston Scientific, BIOTRONIK, and Sorin/ELA.

Sorin/ELA is a European company, so let’s leave that off the list.

BIOTRONIK is privately held; it is one of the largest privately held companies on earth. So no investing there.

That leaves us with the big three. None of these American-based companies solely makes pacemakers. Medtronic is by far the largest company and works on everything from catheters to deep brain stimulation to diabetes pumps as well as pacemakers. The stock is generally well rated by those who track investments.

St. Jude Medical is also a big company and makes heart valves, neurostimulation devices, and catheters as well as pacemakers. St. Jude Medical had a fantastic upsurge around 1999 to the mid-2000s and has generally been plateauing of late. Investment analysts tend to be mixed on this one, possibly because it had a strong past.

Boston Scientific is also a big company that makes multiple products. Its stock price is lower than the other two, for reasons that are quite unclear to me.

This blog is not for investment advice; talk to your stock broker or get reliable information prior to making your investment decisions. But, yes, you may be able to buy stock in the companies that made your pacemaker

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Pacemaker Seatbelt Cushions

On , in Uncategorized, by pacemakerwriter
Make Driving More Comfy for Pacemaker People

Driving and riding can be more comfortable with a special cushion designed to protect the pacemaker

If you have a pacemaker, you have probably run into the problem that nobody talks about much, namely that car shoulder seatbelts can get pretty uncomfortable. Most car shoulder seatbelts are designed to come across the chest roughly in the same area of the implant. This can make driving or riding in a car uncomfortable, particularly for long distances or when you are doing lots of short errands and end up having to belt and unbelt frequently. This handy little cushion is just a little pad that wraps around the seat belt and closes with Velcro fasteners. The beauty of this system is that it’s easy, it’s fast, and you take the cushion with you if you change cars.

It’s a simple thing, but sometimes in life, simple things can make all the difference.

There is a special right now over at Pacemaker411.com.

They’re in black and they all have the name of this website–PacemakerPeople.com.

The special over at Pacemaker411.com is actually for my book (Pacemaker Owner’s Manual),  some DVDs, and the cushion–a whole set. And while the book and DVDs are all about pacemakers, the seat belt cushion also works for short people who find that seat belts rub them the wrong way!

Check it out!

 

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Did you know that pacemakers and leads can sometimes be recalled, just like a defective car? That’s right, and it happens more often than you would think. But before you panic that you might have a device on recall from the manufacturer, let’s take the subject slowly. It may not be as bad as you think.

The Food & Drug Administration (FDA–a government agency based in Washington) regulates the medical device industry, including pacemaker and defibrillator manufacturers. When problems occur in these products, the FDA works with the manufacturer to figure out what to do. Any time that a device experiences a problem, doctors can report it to the FDA and it is shared with the manufacturer. When these reports come in, it allows the FDA and the manufacturer to figure out a strategy.

Sometimes the problems are considered “random failures.” The word failure does not mean the device conks out, necessarily, it means it fails to perform according to specification. And like any mechanical device, pacemakers can sometimes just have a problem. If the problem is very very rare, it may be attributed to a random failure. Your doctor may be able to fix it or he or she may enlist the help of the manufacturer to get it fixed.

But sometimes the same problem occurs repeatedly. The FDA keeps getting reports of the same sort of problem in a certain category of devices, say, all pacemakers of a certain brand manufactured around the same time. The FDA then sits down with the manufacturer and they try to figure out what is going on. In many cases, a voluntary recall is issued. This is a curiously named thing, because although the manufacturer states the recall is “voluntary,” it is usually required by the FDA.

When a recall happens, the manufacturer uses its database to see who has these devices (they keep thorough patient records) and the physicians who implanted them. A notice is set out in the form of what the industry calls a “Dear Doctor” letter. This letter describes the problem, the devices affected, and recommends some actions.

You may get a notice in the mail or you may get a call from your physician if you have a device that is the subject of a recall. You will most likely be asked to come in for a visit so that the problem can be explained to you. The doctor will probably have one or more recommendations as to what to do.

Here are 10 important things to know about pacemaker or lead recalls:

  1. Most recalls cover just a subset of all devices. No company recalls all of their products. A recall is typically for a particular model and often for a particular model manufactured during a certain time. Your device can be identified through its serial numbers. So even if Medtronic has a recall, it does not mean the recall affects your pacemaker. And even if does apply to your particular model of pacemaker, it may not apply to the subset of devices you have. So if you hear of a recall–do not worry until you or your doctor check the serial number of the device.
  2. Every recall is different. There have been some relatively “minor” ones and some less minor ones. If you have a recalled device, be open minded and listen to your doctor or nurse explain the situation. Some recalls may just involve having a “software patch” put into the device which involves an office visit and a session at the programmer. Other recalls may require you to see the doctor more often but otherwise take no special steps.
  3. In some recalls, a subset of devices are identified that have the “potential” to have a problem. In such cases, you may be told that you have a certain device and 10% of those devices encounter a problem. This means that even though your device is technically “on recall” you may be in the 90% of people who do not have a device with a problem. In many cases, not all “recalled devices” are going to experience a problem.
  4. The doctor or nurse will recommend some options for you. Sometimes the options are very simple (programming session, accelerated follow-up visits) and sometimes they are more drastic (remove and replace device). You need first of all to ask: what is the worst case scenario? That will help you understand the maximum adverse impact that could happen to you. In some cases, a device is recalled because it may drain the battery faster than normal or it may not allow certain programmable functions. In other cases, you may find out that your device might stop working properly and leave you unprotected. Know what is the worst that can happen.
  5. Next, find out what solutions are out there. The FDA and the manufacturer work together to come up with what can be done to alleviate the problem. In some cases, one solution is so easy and works so well that it is a no-brainer. In other cases, you may be presented with some choices. If you need to have a device removed and a new one implanted, know that there are risks associated with that. Find out the risks associated with each of your available options.
  6. Your physician’s office will talk to you about the financial impact of the recall. In most cases, you will find insurance will cover the problem. If there are special provisions for the recall, talk to your doctor about them upfront.
  7. Most manufacturers do not put a lot of information on their website about recalled products. The reason is not that they want to hide valuable information; the reason is that clinical care for a pacemaker or defibrillator patient is highly individualized. I have an uncle who has a defibrillator lead that is under recall. He was offered a choice: get it removed and replaced or watch it closely. Since he is 90 years old, he opted for the wait-and-watch method. Another younger, fitter person might have chosen to have the lead replaced. Manufacturers usually spell out their recommendations to doctors and expect doctors to help interpret them individually, patient by patient.
  8. If you search online about recalled products, you may find crazy, scary information. Get your information from your doctor.
  9. If you are not sure you have a product under recall, contact your physician and ask. This is a better method than trying to find out recalls from the FDA website. It’s possible to access the FDA site (they’re fda.gov) but it can get confusing to try to identify your precise product.
  10. If you are not happy with your doctor’s recommendations about the recall or if you feel like you’re not getting the whole story, you should do what you would do in any other medical situation like that. Get a second opinion.

 

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Stress Test

On , in Diagnosis, by pacemakerwriter

Arrhythmia patient having stress testA common test for many cardiac conditions is the so-called stress test. There are two main types: in one, you are asked to perform some sort of exercise to “stress” your heart, that is, make it beat faster. This may involve walking or jogging on a treadmill or riding a stationary bicycle. There is also a chemical stress test, in which the doctor administers drugs that “stress” the heart in order to evaluate the heart’s response. If you are healthy enough for a physical stress test, that is usually the one you will get, in that it allows the clinical team to see how your heart responds to exertion under the most normal, natural conditions.

Of course, it does not feel very natural. The nurse will apply electrodes to your body, often a dozen or more, to capture all of the electrical activity from the heart. If you’ve ever wondered how this works, the heart generates electricity; in fact, by detecting this electricity, we can interpret what the heart is doing. The electrical energy produced by your body is strong enough to be picked up on the surface of the skin–that’s why the doctor wants the electrodes on the skin. The electrodes are placed in certain “vectors” or angles to capture the electrical signals which are then “translated” into a surface electrocardiogram or EKG. Surface refers to surface of the skin. Electrocardiogram means a picture (gram) of the heart’s (cardio) electrical activity (electro). This is abbreviated ECG or EKG in the hospital. I don’t know why they call it EKG, but I heard that it was to make sure nobody confused an ECG with an EEG, a brain-wave machine.

As the heart is stressed, it should start to beat more rapidly. Certain changes in the rhythm should occur, for instance, the time between the atrial contraction (beating of the upper chambers) and the ventricular contraction (beating of the lower chambers) should shorten. This is called the AV delay. In a normal healthy heart, the upper chambers beat slightly ahead of the lower chambers, but that time lapse (measured in fractions of a second) shortens with exercise … at least it should.

A stress test can evaluate what doctors call chronotropic competence or, the more common term, chronotropic incompetence. A person with chronotropic incompetence has a heart that does not beat sufficiently fast to keep up with activities. Chronotropic incompetence is not specifically a rhythm disorder, but it can be corrected by a rate-responsive pacemaker which helps the heart beat sufficiently rapidly during times of exercise.

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If you are a pacemaker person, you have probably grown frustrated with the fact that there are allegedly certain things you can and cannot do now that you have an implanted pacemaker–but there is no definitive list anywhere that names what can and cannot be done. Can you use an electric shaver? Can you fix a lawn mower? Can you wear jewelry that has a magnetic clasp? What if you live near power lines … is that a problem? And how do you get through airport security?

There is a reason that most doctors and manufacturers do not provide you with a list of equipment and activities spelled out in black and white. The real answer to what you can and cannot do is simple: “It depends.” It depends on the pacemaker (most today are very well shielded from external forces but some older ones may be less well shielded) and it depends on the implant location (the deeper the implant, the less likely outside waves can reach it) and it depends on the source of the interference.

The old story about pacemaker people not being able to use a microwave is a myth, at least it has become a myth. Pacemakers and microwaves are both well shielded; the microwave does not emit anything that would disturb the pacemaker and, even if it did, the pacemaker is shielded. Most household appliances are fine to use. Same thing with electric razors and other ordinary devices.

When it comes to the workshop, there are situations where certain electromagnetic fields can interfere with the pacemaker. The trouble is that these can be highly specific. So in an effort not to scare everybody away from working on any engine, most device experts will simply tell you that working on an electric motor may or may not interfere with your device.

How do you know? If you experience interference, you will feel funny. For most pacemaker people you will start to feel lightheaded, woozy, dizzy, or just not right. Interference of this sort does not damage the pacemaker. The best way to get back to normal is to distance yourself from the source of interference. Either step away or, if possible, turn off the interference. Once you know if something bothers your pacemaker, you can then avoid it.

Most pacemaker people do not run into these issues. However, there are some things that truly can give you a problem.

1. Arc welding.

2. Being close to high-tension lines.

3. Industrial magnets.

4. Bumper cars. (No, I’m not making that up. In fact, many amusement park rides can interfere with your device but bumper cars is the worst.)

And finally what about security check points or scanners at airports? You should be able to pass through these without interference. In fact, depending on your size, your implant, and how sensitive the metal detector is, your pacemaker may not even set it off. On the other hand, if you want to play it safe, just show your pacemaker ID card to the security officials and they will tell you how to proceed. But if you do walk through airport security as a “regular person” instead of a “pacemaker person,” you may very well be able to do so. And even if the airport scanners did interfere with the device, you move through them so quickly it’s a non-issue. Who lingers under a metal detector for minutes?

There is one thing that can cause pacemaker interference that few pacemaker people realize. Many department stores and other large discount stores have theft-detection systems. These are electronic surveillance systems that help the store detect shoplifting. In such stores, some or all merchandise has some kind of sensor attached to it; when you pay for merchandise, the sensor is deactivated. The surveillance system tries to track still-active sensors, particularly as they near the door. The problem with these theft-deterrent systems (as they are sometimes called) is that few stores post notice about them. They are designed to be invisible. As a general rule, you as a pacemaker person can roam around a store with electronic surveillance with no problem. But if you stand or sit in a certain area that happens to be near a beam of this system, it can affect the pacemaker.

  • If you are ever in a big store and start to feel funny, woozy, or even faint, take notice where you are … and move away. Even three or four steps can be enough.
  • If it’s an antitheft system that is causing this, you were probably standing or lingering or sitting in one spot for a while. (If you were walking through the store and felt faint, it is unlikely to be the store’s surveillance system at fault.)
  • You should start to feel better as soon as you move out of the “danger zone.” If you know this happens to you in certain stores, you can still shop there providing you do not stand still very long or stand still only in places you know will not affect you. (Most of these surveillance systems monitor the door areas rather than deep in the store.)

The bottom line is that the average pacemaker person will not likely experience device interference from appliances or equipment. People with industrial jobs might, but they may be able to work with a physician of a device company representative to figure out solutions.

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Recalls 101

On , in Recalls, by pacemakerwriter

Pacemaker, ICD, and lead recalls, like Riata lead recall

If you or someone you know is affected by the lead recall involving the Riata or Riata ST defibrillation leds from St. Jude Medical, you may not know what to do next. Actually, medical recalls are nothing unusual–this is not the first medical device recall in history, nor will it be the last. A voluntary recall (the FDA term for the event) occurs when a manufacturer together with the FDA determine that there is sufficient reason to notify doctors about a problem with a product. This problem can be anything–it might be a software glitch in the pacemaker that causes a special feature to work improperly, it may be a technical problem in a pacemaker that causes the battery to deplete prematurely, or it may be a malfunction or failure to work properly.

In a voluntary recall, the manufacturer identifies the products involved. This may be a brand name and model number or it may be a subset of those products, such as Model 1257 Acme Pacemaker, serial numbers from 1001 to 1200. Because manufacturers maintain comprehensive records on devices and sales, the manufacturer can identify where those specific products went, right down to the doctor who implanted them and the patient who is wearing them. The manufacturer then notifies the physician who is tasked with informing the patients. In some cases, patients may be notified directly. When this information arrives, it explains the problem, it may offer a potential solution(s), and usually requests that the patients visit the doctor to discuss the matter or take steps to fix the problem.

Of course, this system may break down if the manufacturer does not have the latest address for the patient–and in today’s mobile society, who thinks to notify the pacemaker company when we move? (You actually should–if you move, notify the manufacturer of your pacemaker and leads. If you don’t know how to do this, go to the website, find the toll-free number, and ask to speak with the “Patient Records” department. All the companies have one.) If you no longer see the doctor who implanted your device or if this doctor does not have your latest address, you may not get notified about a potential recall.

You can check the FDA’s website for recalls. This exercise may scare you or it may make you feel more confident–there are lots of recalls. You can also contact the manufacturer to learn about any recalls with its products. But if you have been notified about a recall, here is what you need to remember.

  1. When you are notified about a recall, you should get some information. It may be in the form of a letter or a document or perhaps a clinician will sit down with you and explain the problem. Do not be afraid to ask questions or to take notes. You can also call your doctor back after this meeting if you have questions later on. The most important thing in dealing with a recall is that you understand what the problem is.
  2. If you found out about a recall but not from your doctor (or if you have moved or changed doctors), see a qualified physician, bring your pacemaker ID card, and bring along any information you might have about the recall. Chances are, if you are seeing a pacemaker specialist, your new doctor will already be aware of the problem and can help explain it to you.
  3. Sometimes a recall does not affect all products with a certain brand number or a certain model number. There could be a recall for the Acme Model 123 pacemaker but only involving devices with a serial number between 8000 and 9000. Your physician can help you determine if the recall even affects you.
  4. Sometimes a recall occurs because you may be at risk of something, but that something usually does not happen. For example, the doctor may know that 20% of leads (like the one you have) fail within five year. Look at this another way: 80% of those leads do not fail in five years. A 20% failure rate is high, but it does not mean that your lead will fail. In fact, odds are good it won’t–but you should not take unnecessary risks with your health!
  5. Most recalls involve some recommended action. In many cases, you will be confronted with a choice. Most medical procedures carry with them risks and benefits, so you’ll have to decide what options you have, how beneficial they are, and if they are worth the risk.
  6. Some recalls do not involve any action at all. There are some recalls where the manufacturer simply recommends an extra follow-up visit a year or a specific test. Some recalls involve simple fixes, like a programmer session where new software can be used to “patch” a glitch. But some recommendations may include having a product removed and replaced, and that involves surgery.

Your doctor is by far the best source of information for managing your recalled product. Discuss the problem and recommended solutions. Medicine is “one size fits all.”  Many times manufacturers recommend several solutions because no one solution is the optimal choice for all patients. Your doctor should take into consideration your medical history, your arrhythmias, the type of pacemaker you have, your overall health, medications you take, your age, and even your living situation (do you live alone? do you go to work every day?) to figure out the most appropriate solution for you. A doctor seeing two patients with the same recalled lead may recommend the first person have the lead surgically removed and the second patient leave the lead in place but have it X-rayed and monitored. The first patient may have a lead that is already showing signs of damage, while the second patient may be too frail and sick for surgery and the lead may look good on X-ray.

If you do not agree with your doctor’s recommendations or you are not sure you are getting the best advice, you can always seek a second opinion. In many cases, you do not need to make up your mind overnight. You can think about the problem and solutions, discuss it with your family, and plan the next steps with your physician.

One question that comes up frequently is payment. When a company recalls a product, who pays for getting it fixed or replaced? That is a question that cannot be answered generally; talk to your physician or the accounting people at the clinic to figure out the costs. Many factors can influence how payment is handled. Most pacemaker companies provide a warranty for pacemakers, ICDs, and leads, but these are pro-rated based on time. For example, if a pacemaker costs $10,000 and is expected to last 10 years, you can get the full $10,000 if it fails right out of the box or in the first few days (very rare occurence). But if you’ve had the pacemaker for five years, the company will not refund the full $10,000 because you have had five years of service from the device. You’d get a portion of the price, probably around $5,000, in that case. It is important to talk to your physician or the clinic/hospital about costs. Do not be embarrassed about this. Recalls are highly unusual cases, and there is nothing wrong with knowing what charges to expect and who is handling them.

Sometimes people wonder if there are any pacemaker companies that are “better” or “worse” in terms of recalls. Every one of the big-five pacemaker companies has had recalls and there is no evidence to suggest that one company is better or worse than the others. Pacemakers and leads are highly sophisticated, technologically advanced products that function in the most hostile environment on earth–within the human body. Some of them fail or do not work according to specification. That is not only expected, it is practically unavoidable. Pacemaker manufacturers know they can never build the perfect device that functions 100% reliably in every case. The goal is to build products that are safe and reliable and to manage the inevitable problems swiftly and safely.

 

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Riata leads from St. Jude Medical recalledIn an unusual move, the Food & Drug Administration in the United States issued a media release relating to certain defibrillator (ICD) products manufactured by St. Jude Medical. You can read the entire release about Riata leads on the FDA website. The announcement relates to leads with the brand name Riata and Riata ST. These are insulated wires, also known as leads, that are plugged into an implanted defibrillator (ICD) at one end and are fixated on the inside of the heart. When the ICD delivers defibrillation therapy (a shock) to restore normal rhythm to a fibrillating heart, the electrical energy travels through these leads. The leads are made by St. Jude Medical but can be used with an ICD device made by any company. People with these leads are urged to get X-ray or other images of the lead “to help guide treatment.”

In November 2011, St. Jude Medical recalled these leads because of reports of “premature erosion of the insulation around the electrical conductor wires.” This is also known as insulation failure, that is, the leads can wear through the insulation and this, in turn, can result in electrical shorts. The idea behind the X-ray or other imaging is to allow a physician to assess whether the lead exhibits any signs of such insulation failure. While Riata and Riata ST have been recalled, not all of these leads fail. However, these leads are susceptible to insulation failure and it is impossible to know from just the model number or other information which ones might fail.

St. Jude Medical reports that about 79,000 Riata or Riata ST leads are implanted in U.S. patients. St. Jude Medical stopped making the leads in 2010 and recalled them in 2011. If you have a Riata or Riata ST lead, you should contact your pacemaker doctor and ask about an X-ray or image that can help you assess the state of your particular lead. Most Riata leads do not fail.

If you are unsure what lead you have, here are some questions to ask:

  • Riata and Riata ST leads work only with defibrillators. If you have a pacemaker (no shocks), you do not have a Riata lead.
  • If you got a lead after 2011, you do not have a Riata or Riata ST lead because they were no longer sold. It’s unlikely you have a Riata or Riata ST lead if you got it after 2010, because they were no longer manufactured.
  • If you have an ICD from St. Jude Medical you may or may not have a Riata–Riata works with any brand defibrillator and it is not unusual for a physician to use leads from one manufacturer with an ICD device from another.
  • If you have a device ID card or other paperwork from your ICD implant, it may specify which leads you have, but not all people have such paperwork and not all paperwork names the type of leads.

 

If you do not know if you have a Riata or Riata ST lead, contact your physician and make sure you do not have a lead under recall. It is possible that you can have a recalled lead and not know it. In most cases, you should have heard from your physician, clinic, or St. Jude Medical already if you had a recalled lead–but sometimes that does not happen. It pays to ask.

If you have a Riata or Riata ST lead that is at risk of failure, this can be a serious concern. Insulation failure can allow some of the conductors of the wire to externalize or move outside of the insulation. This can cause the lead to malfunction. It can short out and cause an arrhythmia. It can also cause the lead to fail so that if you have a dangerous arrhythmia, the lead will not allow shock therapy to be delivered. These are potentially life-threatening situations.

Many failures in Riata and Riata ST leads have shown up in X-rays or other images, which are relatively easy, fast, and safe methods of getting valuable information. If you have a Riata or Riata ST lead and it is determined to be at risk of failure or in the process of failing, your doctor will discuss options with you. In some cases (but not always) he or she may advise you to have the lead removed and replaced with another brand of lead. However, the FDA does not recommend that Riata and Riata ST leads be routinely removed. Lead removal (also called lead extraction) is a surgical procedure and all surgical procedures carry with them some degree of risk. In other words, your doctor needs to evaluate with you your individual potential risks and benefits.

 

 

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