St. Jude Defibrillator & Therapy Device Lawsuits - Battery Failure
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.
What is the Purpose of the St. Jude Defibrillator and Therapy Device
ICDs and CRT-Ds are medical devices implanted in patients with heart rhythm disorders such as bradycardia (slow heartbeat) and tachycardia (rapid heartbeat) to provide an electrical shock or pacing to remedy the rhythm disturbance.
The devices provide pacing for slow heart rhythms, and electrical shock or pacing to stop extremely fast heart rhythms. CRT-Ds are also used in the treatment of heart failure.
ICDs and CRT-Ds are implanted under the skin in the upper chest area and have connected insulated wires which run from the device into the heart.
Why are the St. Jude Defibrillator and Therapy Device Lawsuits Being Filed
ICDs and CRT-Ds are powered by lithium-based batteries which are generally capable of functioning without need for replacement for several years. Following implantation, an ICD’s battery power slowly begins to deplete until it reaches a certain charge level at which point it sends a notification to the patient informing them it’s time to have the battery replaced.
This notification, known as an Elective Replacement Indicator (“ERI”) and described as a vibration and/or auditory alert, is sent when the battery reaches approximately three months-worth of remaining battery life so the patient has sufficient time to see a physician for battery replacement.
The St. Jude ICDs and CRT-Ds have a potential defective battery that can quickly lose its charge without providing adequate warning, sometimes leaving only hours or days to get the battery replaced before it fails entirely. This failure can prevent the devices from providing needed pacing or shocks.
The patients most at risk are those with pacemakers.
Has There Been a Recall of the St. Jude Defibrillator and Therapy Device
The FDA initiated a formal recall of the St. Jude ICD and CRT-D medical devices in October 2016. The FDA designated the action a Class 1 Recall, which is the highest and/or most serious level, and involves products that can predictably cause severe health problems including injury or death.
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|
To determine whether your specific device is subject to the recall, you can input your model and serial number into the St. Jude Medical database by going to St. Jude Premature Battery Advisory.
St. Jude Defibrillator and Therapy Device Lawsuit News
FDA sends St. Jude a warning over two high-profile device issues
Food and Drug Administration inspectors said that St. Jude officials systematically underestimated the true risks facing heart-device patients, even after one person died in 2014. Further, seven patients were implanted with defibrillators after St. Jude recalled more than 400,000 of the devices. To read more, click Star Tribune - FDA Warning
St. Jude Shipped Older Versions of its Heart Device Seventeen Months After Key Design Change
Although St. Jude had fixed the problem that led to a recall of the devices back in 2015, the company kept selling its stock of older units. St. Jude acknowledges that it continued to ship its stock of old devices for 17 months after making a design improvement that reduced the potential for the device to lose power unexpectedly. To read more, click Star Tribune - Heart Device
St. Jude Recalls Heart Devices Due to Battery Issue
The device maker, in a letter to doctors, said potential battery depletion could occur among an estimated 398,740 company implantable cardioverter defibrillators worldwide—devices used to shock a dangerously racing heartbeat back to its normal rhythm. All contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit. To read more, click Fortune
Battery Problems in St. Jude Medical Defibrillators
The batteries on thousands of implantable heart defibrillators made by St. Jude Medical Inc. can suddenly and unexpectedly run out of power, the company said in letters sent to patients and doctors on Tuesday. To read more, click WebMD
FDA and Scientific Studies Regarding St. Jude ICD & CRT-D
The FDA Issues Class 1 Recall of St. Jude ICD & CRT-D
St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit. To read more, click FDA Medical Device Recall
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices
FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. To read more, click FDA Safety Communication