The lawsuits involving the St. Jude Implantable Cardioverter-Defibrillators (“ICD”) and Cardiac Resynchronization Therapy Devices (“CRT-D”) are being filed because the battery in the medical devices can fail without providing enough warning to patients that the battery needs replacing, and might not function when needed.
The devices are supposed to issue a ‘warning’ vibration of low battery at least three months before the battery fails. In some cases, the defibrillators issue a warning vibration just 24 hours or less before battery failure.
This problem could present serious medical complications for some patients who had a St. Jude defibrillator implanted, including serious injury and possibly death. So far, at least two patients have died due to a malfunctioning defibrillator, which has spurred wrongful death lawsuits. Other lawsuits are pending, having to do with the company allegedly failing to warn patients about problems with its Riata defibrillator leads.
The devices, which are officially known as implantable cardioverter defibrillators, and cardiac resynchronization therapy defibrillators, are affected by potential, premature battery depletion. The affected devices were made before May 2015.
The company’s implantable defibrillators shock the heart into a steady rhythm if it stops having a regular beat. They are implanted under the skin in the upper chest. The devices have wires known as leads that are attached to the heart and regulate how the muscle beats. Defibrillators can help people with either bradycardia – slow heart beat – and those with tachycardia – fast heartbeat.
Shocking the heart into a regular rhythm regularly requires the product to have a strong battery. Experts say that the devices would most likely fail after three or four years of use.
The problem was known since 2014; St. Jude worked with Duke University researchers who discovered what they called lithium cluster formation. The failure rate for the defibrillators in that study was .6 percent.
According to the company’s medical director, the company’s analysis of the problem found that while there was a problem with lithium cluster failures in the devices, the rate of failure was very low.
The defibrillators also can work as pacemakers for some patients, and that function is affected by the problem.
The recall involves the following devices which were manufactured between January 2010 and May 2015.
|Device Name||Model Numbers|
|Fortify VR||CD1231-40, CD1231-40Q|
|Fortify ST VR||CD1241-40, CD1241-40Q|
|Fortify Assura VR||CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q|
|Fortify Assura ST VR||CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q|
|Fortify DR||CD2231-40, CD2231-40Q|
|Fortify ST DR||CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q|
|Fortify Assura DR||CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q|
|Fortify Assura ST DR||CD2363-40C, CD2363-40Q|
|Unify Quadra||CD3249-40, CD3249-40Q|
|Unify Assura||CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q|
|Quadra Assura||CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q|
|Quadra Assura MP||CD3269-40, CD3269-40Q, CD3369-40C|