St. Jude Heart Implants Experience Fatal Battery Malfunction
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
In the United States, an estimated 800,000 people rely on implantable defibrillators to regulate their heart rhythm. However, when this life-saving device starts malfunctioning, the consequences can be fatal. This was the case when St. Jude’s Implantable Cardioverter Defibrillator (ICD) started experiencing battery malfunctions. These malfunctions resulted in seemingly harmless glitches such as decreased battery life, but a dead battery at the wrong time could result in the patient not receiving crucial regulating shocks or pacing.
Among the various heart implant devices St. Jude manufactures, the affected devices are the Implantable Cardioverter Defibrillator and the Cardiac Resynchronization Therapy Defibrillator (CRT-D). Both devices are implantable minicomputers inserted in the upper chest area of the patients. The devices are intended to provide pacing for slow heart rhythms, but more importantly, these devices provide mostly unnoticeable shocks when it detects abnormal heart rhythms in the patient. The CRT-D device has more importance because it acts as a specialized ICD meant for patients suffering from heart failure. These devices are even equipped with additional wires attached to the left ventricle. In fact, CRT-Ds have been found to decrease mortality rates among patients with mild heart failure.
Thousands of patients rely on these devices to monitor their heart rhythms and defibrillate when abnormal rhythms appear. That is why a decreased battery life can prove to be extremely dangerous for patients. In October 2016, the FDA issued a recall for patients using ICDs and CRT-Ds advising to potentially expect a shortened battery life. The FDA attributed the battery failure to abnormal electrical connections caused by the formation of lithium clusters. As a result, ICDs and CRT-Ds are more prone to die out quickly and be unable to deliver life-saving pacing or shocks when necessary, which can result in fatalities.
Up till now, the FDA has determined premature battery depletion to be associated with one death in the U.S. because the device was unable to provide shocks when necessary. In addition, there have been 39 reported cases of patients in the U.S. not receiving pacing due to battery depletion and experiencing dizziness or fainting. However, there are a number of premature battery depletion incidents that go unreported, which means the number of patients affected may be even larger.
This is not the first time St. Jude ICDs have experienced malfunctions. Back in 2014, St. Jude’s ICDs experienced lithium related battery issues resulting in shortened battery life. Much like in 2016, these ICDs were impaired by the formation of lithium clusters, which in turn creates short circuits that deplete the battery. In response to this issue, St. Jude announced battery design changes in May 2015. However, St. Jude continued to sell older ICD units that still had battery depletion issues. St. Jude continued to knowingly sell faulty units up to 17 months after the announced battery design changes.
Currently, the FDA estimates 349,852 affected devices remain implanted worldwide. If you or your loved one are currently implanted with a St. Jude ICD or CRT-D and are experiencing battery malfunction, it is advised you seek out medical attention and legal counsel to ensure you and your loved ones receive compensation for your suffering.
By: Giselle Cornejo