Fleming, Nolen & Jez Investigating the St. Jude Medical ICD & CRT-D Devices

The attorneys at Fleming, Nolen & Jez are currently investigating serious injuries caused by safety defects found in the St. Jude Medical ICD & CRT-D devices.

10,000 different types of ICD's are implanted every month. ICD means Implantable Cardioverter Defibrillator or the Cardiac Resynchronization Therapy Defibrillator (CRT-D).

It is designed to deliver two levels of electrical energy: a low energy shock that can convert a beating heart that is in an abnormal rhythm back to a normal heartbeat, and a high energy shock that is delivered only if the arrhythmia is so severe that the heart is only quivering instead of beating.

What does it do and what types are available. Pacemakers are most commonly used in patients whose heartbeat slows to an unhealthy low rate. ICDs are used in specific patients who are at risk for potentially fatal ventricular arrhythmias (an abnormal rhythm from the lower heart chambers, which can cause the heart to pump less effectively). A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern. There may be other reasons why your doctor advises placement of a pacemaker or ICD.

It has a generator, one or more leads, and an electrode for each lead. These components work very much like a pacemaker. An implantable cardioverter defibrillator (ICD) looks very similar to a pacemaker, except that it is slightly larger.

Most cardiac pacemaker systems generally include a subcutaneous pulse generator placed in the chest wall and transvenous pacing leads affixed to the heart tissue.

Infections might occur after the surgery however these are rare. Lead-related complications include perforation, lead displacement, lead fracture, and insulation defects. The majority of ICD generator-related complications consisted of prophylactic generator replacements due to manufacturer recalls. These would require reoperation and additional hospitalization. 95.7 percent of re-implantation surgery occurred due to end of battery life.

Patients who experienced complications on average stayed 3.4 days longer. Re-implantation-related infections cost more per stay and stayed an extra 9.6 days on average.

The FDA inspection revealed that reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”) forming within the battery, and causing a short circuit.

These are the St. Jude Medical ICD and CRT-D models manufactured before May 2015 have been recalled. The device maker, in a letter to doctors, said potential battery depletion could occur among an estimated 398,740 company implantable cardioverter defibrillators worldwide.

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Categories: Medical Devices