May Cause Sudden Cardiac Arrest
Certain St. Jude Medical Defibrillators May Cause Sudden Cardiac Arrest
St. Jude Medical Implantable Defibrillators
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for patients with abnormal heart rhythms. ICDs and CRT-Ds are implanted in the upper chest area under the skin, with wire “leads” connecting the device to the patient’s heart. The lithium-based batteries that power the defibrillators are prone to lithium build-up, or “clusters,” which can cause premature battery failure and sudden cardiac arrest.
Normally, patients receive an alert three months before the device needs to be replaced, but due to the battery failures, some batteries have run out of power within 24 hours of the patient receiving a low battery alert. According to St. Jude, in the affected devices, there is no way to accurately predict when the “lithium clusters” will cause the battery to deplete—and no way to give patients enough of a warning replace the battery.
As of October 2016, two deaths have been reported to be caused by the failed defibrillator batteries and approximately 200,000 at-risk devices remain implanted in patients in the U.S. Other reports of dangerous side-effects include fainting and dizziness. St. Jude advised that patients dependent on pacemakers who rely on an affected device should be treated as a “medical emergency” when their devices reach low battery mode.
On October 10, 2016, St. Jude recalled affected devices that have not yet been implanted and advised healthcare providers not to implant any unused affected devices. The following day, the FDA issued a safety communication warning consumers that the batteries in certain ICD and CRT-D devices may deplete prematurely: affected models include Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices manufactured between May 2010 (when the devices received FDA premarket approval) and May 2015.
St. Jude’s recall and correction of the affected devices could potentially lead to tens of thousands of early device replacements for patients understandably fearful of premature battery failure.
What Does This Mean for You?
Experienced attorneys are investigating the risks of St. Jude ICD and CRT-D defibrillators and their batteries and are monitoring all developments. If you or a loved one received a St. Jude ICD or CRT-D defibrillator implant and experienced complications, please contact us.