Defective batteries in certain Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and some medical Implantable Cardioverter Defibrillators (ICDs) manufactured by St. Jude Medical can cause these heart devices to fail prematurely and without sufficient warning. Defibrillators are surgically placed metallic implants that are designed to treat dangerous heart rhythms by delivering tiny electrical shocks to the heart in order to prevent heart failure or cardiac arrest that can lead to death.
In October 2016, the Food and Drug Administration (FDA) announced a recall of the certain defibrillators after two deaths and 47 other medical situations were associated with the defective batteries. According to the FDA, the recall is considered to be a class-1 recall (the most serious type) and could affect as many as 350,000 victims worldwide. The products affected are models that were manufactured from January 2010 through May 2015. These devices were distributed between February 2010 and October 2016. Defibrillators included in the recall are:
- Assura Implantable Cardioverter Defibrillators
- Assura Cardiac Resynchronization Therapy Defibrillators
- Fortify Implantable Cardioverter Defibrillators
- Fortify Cardiac Resynchronization Therapy Defibrillators
- Unify Implantable Cardioverter Defibrillators
- Unify Cardiac Resynchronization Therapy Defibrillators
Specific model numbers of these devices are listed at the FDA website.
How Serious is the Defective Defibrillator Battery Problem?
When working correctly, these life-saving devices treat patients with conditions that cause irregular heartbeats like bradycardia and tachycardia by delivering tiny electric shocks to the heart muscle. In the defective devices, however, the lithium batteries that supply power to the defibrillators incur a build-up of deposits. As a result, the batteries run down quickly and unexpectedly. Under normal circumstances, the device would alert the patient several months before the battery life is depleted so he or she would have ample time to have the battery replaced. With the defective devices, however, power can be lost within 24 hours of when the alert is issued. According to St. Jude Medical, victims with these types of defibrillators should have the batteries replaced immediately after receiving the vibrating alert from their device.
In 2015, the device manufacturer made a design improvement that significantly reduced the risk for premature battery failure. Shockingly however, St. Jude Medical continued to distribute the older, defective, and dangerous devices for a full 17 months afterward.
Legal Remedies For Victims of Defective Devices
Victims who have been affected by these defective medical devices may be able to receive compensation for medical expenses, pain and suffering, lost wages, and appropriate punitive damages. Contact Reno attorney Matt Sharp for a free consultation.