Defective Implantable Cardioverter Defibrillator Devices – What You Need to Know

An implantable cardioverter defibrillator device, or ICD, is a miracle device. It’s a little box, powered by a battery, that attaches to your heart and records your heart’s rhythm. If it detects an arrythmia – a change in rhythm – it will send an electrical current to the heart. ICDs are a bit different from pacemakers, as they don’t constantly send a current to the heart.

St. Jude Medical sold thousands of these implantable defibrillator devices. To date, 400,000 of them have been recalled because they had bad batteries. At least two people have died as a result of the defective device, and thousands of others have suffered with the pain and stress associated with it.

A quick recap of the St. Jude recall

In 2016, the Food & Drug Administration issued a warning about ICD manufactured by St. Jude Medical before May 2015, saying “of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion.” Since then, the FDA has issued a Class I recall of all St. Jude Medical implantable defibrillator devices for battery failure.

Implantable defibrillators are designed to vibrate occasionally towards the end of their battery life – 5 to 7 years, on average – so that patients know to make an appointment to see their doctor. The St. Jude batteries simply depleted, leaving thousands of people without warning of their impending dead battery.

What went wrong with the batteries?

ICDs use lithium-ion batteries – the same type of batteries in the Samsung Galaxy recall and in e-cigarettes. Over time, small amounts of lithium deposits, called clusters, would build up within the casing of the device (It happens with all lithium batteries.) the company which manufacture red the batteries in the later models of the ICDs, Greatbatch, claimed that glass wool would keep the clusters from forming.

But it didn’t. This design flaw meant that those deposits could come in contact with the other internal workings of the device, causing the batteries to short circuit and drain the power – sometimes within 24 hours. For people who are ICD-dependent, a power failure could literally be the difference between life and death.

Despite the well-documented problem of lithium clusters, St. Jude went on manufacturing the implantable cardioverter defibrillator devices, and only recalled those devices in 2016.

Which models were affected?

• Fortify VR: Model No(s). CD1231-40, CD1231-40Q
• Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
• Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
• Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
• Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
• Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
• Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
• Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
• Unify: Model No(s). CD3231-40, CD3231-40Q
• Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
• Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
• Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
• Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C

My ICD had a defective battery. What do I do?

If you were one of the thousands of people whose implantable defibrillator had a defective battery, you can seek compensation for your medical bills – including those associated with the original and revision surgical procedures – your lost wages, your pain and your suffering. There is currently an MDL (multi-district litigation) underway, and a class-action suit. You can also file an individual lawsuit.

Our law firm has been personally touched by these cases. We know first-hand what you have gone through: the stress, the fear, and the pain; the hassle and risks of a second surgery; the frustration of trying to get the insurance company to pay to replace a device you cannot live without. We also know what it is like to stand next to a person you love and feel helpless that you cannot do more for him or her.

We will fight for justice for you. If you or your loved one suffered because of a defective ICD, our team wants to help. To learn more about our services, or to speak with an experienced mass tort attorney in our Phoenix office, please call 602-266-2002, or complete our contact form today.