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St. Jude Medical ICD & CRT-D

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St. Jude Medical markets a number of Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) products to treat patients with irregular heart rhythms. In October 2016, the company announced a recall for many of its ICD and CRT-D heart devices due to the potential for premature battery depletion. The issue has been linked to two deaths.

Implantable Cardioverter Defibrillator

An implantable cardioverter defibrillator, or ICD, is a small device that is placed inside the chest or abdomen of patients suffering from arrhythmias (irregular heart beats). During implantation, a small, insulated wire is placed on or inside the heart muscle, and attached to the ICD. This “lead” will sense when an abnormal rhythm occurs within the heart’s ventricles (lower chambers). The ICD will then transmit low-energy electrical pulses to restore a normal rhythm.

If the low-energy pulses from the ICD are not adequate to restore a normal heart rhythm, the device will switch to high-energy pulses for defibrillation. The ICD will also emit high-energy pulses if the ventricles start to quiver rather than contract strongly.

Some arrhythmia patients receive a device called a pacemaker to help maintain a regular heartbeat. Unlike an ICD, pacemakers only emit low-energy pulses, and are often used to treat less dangerous heart rhythm disturbances that occur in the atria (upper chambers). However, some ICDs can be used as both pacemakers and defibrillators.

Cardiac Resynchronization Therapy Defibrillator

A Cardiac Resynchronization Therapy Defibrillator, or CRT-D, is a type of ICD that is specifically designed to treat heart failure. The device includes an additional lead that attaches to the left ventricle, and will send an electrical shock to the heart when it senses an abnormal heart rhythm. A CRT-D can provide either lower- or higher-energy therapy to treat heart failure.

St. Jude Recall

In October 2015, St. Jude announced that it was recalling 398,740 ICD and CRT-D heart devices due to a risk of premature battery depletion. The problem had been linked to two deaths, including one in the U.S. So far, 841 devices have been returned to the company for analysis because of this problem. Ten patients, including nine in the U.S., reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion. Another 37 (30 in the U.S.) have reported dizziness.

All of the ICDs and CRT-Ds included in the St. Jude recall notice were manufactured before May 2015. Affected devices include:

• Fortify VR
• Fortify ST VR
• Fortify Assura VR
• Fortify Assura ST VR
• Fortify DR
• Fortify ST DR
• Fortify Assura DR
• Fortify Assura ST DR
• Unify
• Unify Quadra
• Unify Assura
• Quadra Assura
• Quadra Assura MP

Among other things, the FDA has advised patients implanted with the affected St. Jude Medical ICDs and CRT-Ds to register for Merlin@home monitoring, which can alert a physician when a battery is approaching end of life. However, it should be noted that the agency continues to investigate recent allegations of cybersecurity vulnerabilities associated with St. Jude cardiac devices, including the Merlin@Home monitoring system.