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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