The FDA has recalled nearly 400,000 pacemakers made by St. Jude Medical, Inc. because the implantable devices designed to regulate heart rhythm may short circuit or fail, posing a risk of potentially life-threatening injuries.
Symptoms of a short-circuited St. Jude Medical defibrillator battery may include:
- Loss of consciousness
- Chest pain
- Shortness of breath
If you or a loved one rely on a recalled St. Jude ICD or CRT-D and experience any of these symptoms, you should seek medical attention immediately. After you protect your health, contact Cory Watson Attorneys to protect your legal rights.
The experienced product liability lawyers at Cory Watson have recovered more than $2.7 Billion for clients injured by defective medical devices and harmful prescription drugs and we are ready to review your potential case. Our lawyers have decades of experience handling defective medical device cases, and we are ready to help you get compensation for your medical bills, lost wages, and pain and suffering.
Pacemaker Battery Failure
Implantable cardiac defibrillators, or ICDs, are small cardiac devices placed in the chest or abdomen to help patients maintain normal heart rhythm. Oftentimes, these devices are commonly referred to as pacemakers. Powered by batteries, these life-sustaining devices are designed to provide ample warning of battery problems or potential failure. But some defibrillators manufactured by St. Jude Medical Inc. can short circuit, leaving patients with just hours to seek treatment or face severe—or even fatal—health complications.
At Cory Watson Attorneys, we are here to help if you or a loved one has been injured by a recalled St. Jude defibrillator device.
Defibrillators Can Short Circuit Causing Battery Failure
Nearly 400,000 defibrillator devices manufactured by St. Jude Medical Inc. before May 2015 feature a faulty battery design that makes them susceptible to short circuiting, which can cause total battery failure in as little as 24 hours. The devices are supposed to provide three months’ warning of potential battery failure to patients. If the battery dies prematurely, the device will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
FDA Issues Recall of St. Jude Implanted Defibrillators
The U.S. Food and Drug Administration (FDA) has recalled the following St. Jude Medical Inc. cardiac devices manufactured before May 2015:
- Fortify® VR
- Fortify® ST VR
- Fortify Assura™ VR
- Fortify Assura™ ST VR
- Fortify® DR
- Fortify® ST DR
- Fortify Assura™ DR
- Fortify Assura™ ST DR
- Unify Quadra™
- Unify Assura™
- Quadra Assura™
- Quadra Assura MP™
According to FDA officials, more than 800 St. Jude Medical defibrillators have been returned for analysis due to premature battery depletion.
St. Jude received a new warning letter from the FDA related to their implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, commonly referred to as ICDs or pacemakers. The FDA noted that St. Jude had violated the FDA’s guidelines and good manufacturing practice requirements. Specifically related to the battery recall, the FDA noted that St. Jude had improperly categorized battery failures in devices that had been returned to them. Instead of confirming that the batteries had suffered from premature depletion, rendering the device defective, St. Jude categorized the cause of the depletion as “unconfirmed.” This allowed St. Jude to minimize the problem the devices were experiencing. While St. Jude developed a fix to the prematurely depleting batteries, they continued to sell the defective batteries for more than three years after learning of the problem.
Get Help With Your Defibrillator Lawsuit Battery
At Cory Watson Attorneys, we want to help if you or a loved one were harmed by a recalled St. Jude defibrillator. Our attorneys have recovered more than $2.7 Billion for clients, and we are ready to investigate your St. Jude defibrillator injury claim. Contact our 24/7 legal team to get started—just call (877) 562-0000 or complete our free online form.
The Story Behind the St. Jude Pacemaker Deaths and Injuries
by Stephen Hunt, Jr.
St. Jude Medical ICD and CRT-D Recall
In October, 2016, St. Jude Medical recalled multiple product lines of their implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, commonly referred to as ICDs, CRT-Ds or pacemakers. The recalled devices include models in the company’s Fortify, Unify and Assura production lines. 400,000 of these devices were sold worldwide and 200,000 people in the United States have one of the recalled models of the defibrillator.
The reason for the recall is related to the batteries that power these life-saving devices. The batteries are dying without giving the patient ample time to have them replaced. The batteries in these devices were advertised to last for 5-7 years. Under normal circumstances, the patient is alerted that their battery is near the end of its lifecycle via a home monitoring system or when they have a check-up with their cardiologist or electrophysiologist.
When the battery in the device is near the end of its lifecycle, the device is also designed to vibrate occasionally to alert the patient. These warnings are supposed to occur at least three months in advance of the depletion of the battery to allow the patient a sufficient window to schedule battery replacement with their doctor. This is especially important for patients who are 100% defibrillator dependent.
The problem with the batteries in these particular St. Jude devices is that they suffer from a defective design that can cause the battery to prematurely deplete or die within as short of a period as 24 hours. Depletion of the battery means that the device no longer has the power to deliver lifesaving shocks.
The depletion is caused by lithium clusters that form inside the battery. If the clusters form in a way that connects the two internal terminals of the battery, the battery will short circuit and rapidly lose its power. The batteries in these devices were manufactured by Greatbatch, which is now named Integer Holdings.
The battery in the recalled units is not the same as the original battery that powered the devices when they were approved by the FDA. The battery in the recalled devices was added later and was touted by St. Jude as having a novel technology that would result in increased battery life. According to St. Jude’s battery supplement submission, the revised Greatbatch batteries were Q High Rate (QHR) batteries, which use a blend of SVO (silver vanadium oxide) and CFx (carbon monofluoride) chemistries. Apparently, it is this QHR technology that causes the lithium cluster formation and resulting premature depletion.
Interestingly, a subsidiary of Greatbatch filed a patent in December, 2004, that described a battery casing designed to prevent lithium clusters. The patent states that “[a]ccording to the investigators, lithium deposition is induced by a high rate intermittent discharge of a Li/SVO cell and form “clusters” bridging between the negative case and the positive connection to the cathode.” It goes on to conclude that “[the] conductive bridge can then result in an internal loading mechanism that prematurely discharges the cell.”
Lithium cluster formation in lithium batteries is a well-known phenomena in the electrical engineering field. It was known long before the patent noted above. This was nothing new to Greatbatch, and as evidenced by their patent, it was expected.
Fast forward to May, 2014, when Greatbatch files a new patent proposing the addition of glass wool to the electrolyte fluid chamber to prevent lithium cluster formation. Again, the patent describes the formation of lithium deposits that grow large enough to form clusters and contains wording very similar to the 2004 patent. “It is known that lithium deposition is induced by a high rate intermittent pulse discharge of a Li/SVO cell. For a case-negative cell design, high rate pulse discharge can form “clusters” bridging from the negative case to the positive connections for the cathode. The opposite is true for a cell of a case-positive design. In any event, such a conductive bridge can then result in an internal loading mechanism that prematurely discharges the cell.”
The 2014 Greatbatch patent then describes how the addition of the glass wool will fix the problem of lithium cluster formation. “While some amount of lithium deposition may still occur, the dendrites are randomly dispersed within the labyrinth of the loosely packed glass wool, which significantly degrades the ability of dendrites to grow large enough to form a cluster bridging from a structure of negative polarity to one of positive polarity.” This is presumably the patent that provided the fix for the prematurely depleting batteries in the St. Jude devices.
If the “glass wool” patent was filed in May, 2014, one can reasonably assume that St. Jude and Greatbatch knew about the problem for a period of time before that. How long before? Who really knows, but what we do know is that the company was aware of the problem and developed a fix for the problem by mid-2014.
The lithium cluster battery failure mode was identified by physicians at Duke University in a 2014 publication and then in 2015 another physician team at the University of Illinois confirmed that the batteries in the St. Jude devices were subject to premature depletion. Despite these two studies, St. Jude Medical still waited until October, 2016, to take action and recall these defective devices and inform doctors and patients of the problem. There were two confirmed deaths related to premature battery failure by the time of the recall.
Why did St. Jude wait so long? It goes back to the failure mode of the lithium clusters. Apparently, sometimes when lithium clusters form in a manner to short circuit the battery, the clusters can then dissipate back into the electrolyte fluid and not leave any trace that they were there. Sometimes the clusters remain and there is sufficient evidence to link the clusters to the short circuit and rapid depletion. This means that the failure mode is difficult to definitively determine by inspecting the dead battery.
That said, when St. Jude received batteries that had been removed from patients due to premature depletion, and cracked them open without finding evidence of cluster formation, they categorized the failure as “unconfirmed.” This allowed them to underreport the actual number of failures they were seeing in the field and justify not recalling the device because of a “low incidence of failures.”
The FDA caught on to this and in April, 2017, St. Jude received a new warning letter from the FDA related to their defibrillator product line. The FDA noted that St. Jude had violated the FDA’s guidelines and good manufacturing practice requirements. Specifically related to the battery recall, the FDA noted that St. Jude had improperly categorized battery failures in devices that had been returned to them. The FDA chastised the company for waiting so long to recall the devices and acknowledge the battery failure mode. This is a perfect example of profits before patients.
What do you expect from a medical device company that pirates the name of one of the twelve Apostles and St. Jude Children’s Research Hospital, which does amazing work for children across the country? There is no relation between the medical device company and the hospital at all. According to St. Jude Medical’s website, they “applaud the work of the [St. Jude] hospital but are not affiliated with its facility, employees or patients.” Perhaps they should applaud with some of the $1.6 billion that they made off their defibrillator products in 2015 alone.
Stephen Hunt, Jr. represents St. Jude clients nationwide and leads the Cory Watson Attorneys St. Jude Medical Defibrillator legal team. A principal with Cory Watson Attorneys, Hunt is part of a team that has recovered more than $2.7 Billion for clients injured or killed by defective medical devices and harmful prescription drugs.