Implantable Cardioverter Defibrillator Recalls

Important Information About Implantable Cardioverter Defibrillators

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A "recall" of your implantable cardioverter defibrillator (ICD) can be a frightening and confusing experience. Recalls are uncommon, and fortunately only a small minority of people with ICDs are ever affected by them. But that fact doesn't help much when it happens to you.

What Is an ICD Recall?

An ICD manufacturer issues a "recall" when it discovers that some of its ICDs are prone to behaving inappropriately, in a way that may possibly affect the safety of patients who have those devices.

A recall rarely means that your ICD needs to come out. Instead, it means that you and your doctor need to check your device, discuss the issue that triggered the recall, and decide which course of action is best for you.

Why is it called a recall when most affected devices don't really need to be "recalled?" The word recall is required by a federal statute - a statute that was written back in the day when medical devices were rarely implanted. It is easy to recall - to ”take back" - a drug or a non-implanted medical device. It is not so easy, or necessarily safe or smart, to do so when the devices are implanted within somebody's body.

Most recalled ICDs can be safely left in place and managed in some other way, for instance, by programming small changes in how the device functions, doing more frequent follow-up, or even using wireless "remote" follow-up.

What Triggers A Recall?

A recall is issued when some devices have the potential of behaving outside their design expectations.

This is a polite way of saying that these ICDs may have a risk of failure that is higher than the predicted failure rate, or a new type of failure has been identified that may pose a risk to the patient.

An ICD generator is an extraordinarily complex device. It contains hundreds of delicate electronic components, housed in a small metal "can," along with a sophisticated battery and a powerful capacitor.

The ICD is expected to survive for up to six or seven years inside the human body - an extremely hostile, high-temperature, salt water environment that would ruin most electronic devices within minutes.

That such a device has been successfully built is itself an amazing feat of engineering. But the complexity of the ICD generator means that, theoretically at least, there are literally hundreds of possible ways for these devices to "fail."

When a manufacturer submits a new model of ICD to the FDA for approval, one of the documents it must include is a "failure prediction," which is an engineering analysis that predicts how likely that type of ICD is to fail (for one reason or another) over a five-year period. This analysis is based on the likely failure rate of each of the hundreds of components that go into the device. The fact that the predicted failure rate is never zero does not mean that ICD manufacturers are lax or cutting corners. To the contrary, they always are working to improve the safety of the devices they build.

No device made by man is ever perfect and entirely free of the risk of failure. ICD manufacturers are expected to predict that failure rate -- and then live up to it.

The predicted failure rate for a typical, modern ICD is around 1% to 2% over five years. This stacks up very favorably with older ICDs, which had failure rates as high as 20% over three to four years.

What Do You Need To Know When Your ICD Is Recalled?

If your ICD is recalled, there is a lot you and your doctor need to take into account before you decide what course of action to take:

1) Is my ICD actually recalled? Don't trust what you hear on the news. The manufacturer will give your doctor a list of which the specific ICDs are being recalled. You will need your doctor to determine if your device is really on that list.

2) What type of ICD failure is causing the recall? If the failure should actually occur with your device, what can you expect to happen? Would the condition be life-threatening, or "merely" painful or annoying?

3) What are the odds of this failure actually occurring? What are the chances that the failure that is responsible for the recall will actually happen with your device?

4) Is there something about me or the type of arrhythmias I have that would make it more (or less) likely that my ICD would experience this kind of failure, or that would make it more (or less) dangerous for me? For instance, odds of surviving an episode of ventricular fibrillation without a functioning ICD would be small; whereas an episode of stable ventricular tachycardia is often quite survivable.

5) Is there something that can be done short of device replacement that would limit my risk? Can your ICD be reprogrammed to reduce the odds of experiencing a failure, or to reduce the risk of suffering a poor outcome if a failure should occur? Would more frequent follow-up, or using a remote monitoring system, reduce the risk?

6) Are there specific recommendations from the manufacturer or the FDA on how to deal with this recall? Sometimes the manufacturer (always with the oversight of the FDA) will make recommendations on how to best mitigate the risk from the recalled ICD.

The answers to these questions will help you and your doctor decide whether to leave the device in place, or to take it out and replace it with a new one. With most ICD recalls, the risk can be mitigated without replacing it.

If You Are Seriously Considering Replacing the Recalled ICD

If at this point you are leaning toward device replacement, there are a few more factors you should take into account:

1) What are my risks of device replacement surgery? While replacing an ICD is generally considered a fairly benign procedure, there is still a measurable risk of complications. The most feared risk is the risk of infection, which can be a serious problem. The risk of infection with device replacement can be as high as 2% to 3%. Some people (those who have diabetes, heart failure, are particularly obese, or other chronic illnesses) have a higher risk associated with surgery than others.

2) How old is my ICD? Most ICDs need to be replaced anyway every 5 to 7 years, when the battery begins to wear out. If your recalled ICD is 5 years old or older, it might make more sense to have it replaced. If it is only 6 months old, you might lean more toward not having replacement surgery.

3) What is the risk of failure with the new ICD your doctor proposes to implant? This may seem like a silly question, but it's not. As mentioned earlier, every new ICD that is approved by the FDA comes with a predicted failure rate, which is always some number greater than zero. If you compare the projected failure rate of your recalled ICD with the failure rates of the devices that can be used as a replacement, you may be surprised to find that there's not much difference between the two.

Summary

An ICD recall can be a scary experience, but it doesn’t need to be. Remind yourself that when it comes to ICDs, the word "recall" most often does not mean what it seems to mean.

Learn as much as you can about the recall issue itself, and how it applies specifically to you and your ICD. Your doctor should discuss all of this with you in detail, and to help you arrive at a course of action that is best for you.

Sources:

Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 2010; 122:1553.

Gould PA, Krahn AD, Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006; 295:1907.

Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001; 286:793.

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