If you have the Boston Scientific S-ICD device implanted to treat an irregular heartbeat, you may be at risk for life threatening complications.

Patients may have undergone surgery for an implantable cardioverter defibrillator, or ICD, in order to treat their irregular heartbeat patterns, or arrhythmia. Although these devices work to save lives by correcting abnormal heartbeats, ICDs entered the news in December when Boston Scientific recalled their Emblem S-ICD due to concerns that the device can fracture.

If you have this ICD, you may need to take action to protect yourself from potential complications. Afterwards, you may also be eligible to take legal action against the manufacturer.

This is not the first legal action taken against Boston Scientific. In 2019, the company settled around 50,000 claims over issues with their transvaginal mesh.

What is an Arrhythmia?

An arrhythmia is an irregular heartbeat which is too fast, too slow, or beats irregularly. The most common type of arrhythmia is atrial fibrillation, sometimes shortened to “a-fib,” which involves an irregular and fast heartbeat.

In some cases, patients may not know that they have an arrhythmia until they have medical testing done. In other cases, they may experience symptoms such as chest palpitations, chest pain, shortness of breath, and sweating.

According to Medline, there are several causes of an arrhythmia. Congenital heart defects or past heart attacks can cause arrhythmias, though lifestyle factors such as stress, smoking, and medications can also impact the heart’s rhythm.

How Do ICDs Treat Arrhythmias?

ICD devices treat arrhythmias by monitoring heart rhythms for abnormal heartbeat patterns. When an arrhythmia is detected, the device shocks the heart to correct it. This prompt treatment allows patients to avoid the more serious complications associated with arrhythmias such as sudden cardiac arrest, strokes, and heart failure.

What Should I Do If I Have the Recalled Boston Scientific S-ICD Device?

Unfortunately, if you have an ICD to treat an arrhythmia, you may have the Boston Scientific S-ICD which was recalled in December 2020. The manufacturer recalled nearly 20,000 of their devices after receiving 26 reports of injuries and one report of death.

According to the recall announcement from the U.S. Food and Drug Administration (FDA), the electrode on the device responsible for shocking the heart is at risk for fracturing while in the body. If the S-ICDs fracture, patients may not be able to receive treatment for the life-threatening situation their device is intended to provide.

As a result of this risk for fracturing, doctors have been encouraged to enroll their patients in at home monitoring through Boston Scientific’s Latitude remote monitoring program and check the performance of the recalled devices during regular in-office follow up appointments.

If this monitoring shows potential issues or breakage in the device, patients may need to undergo imaging such as X-rays to confirm electrode breakage. Should the ICD’s electrode be or become fractured, patients will need to undergo additional surgery to remove the damaged device and replace the ICD.

Although taking these steps is required to ensure patient safety, consumers may find themselves frustrated by these necessities. Even if patients manage to correct their ICDs’ damage before suffering from complications such as heart attacks, strokes, and heart failure, they may be left with significant medical bills from routine checks, imaging, and surgery.

Injured consumers may be eligible to take legal action against Boston Scientific and recover compensation through a lawsuit. Attorneys are interested in speaking to patients whose Boston Scientific S-ICD failed and resulted in complications.