We are extremely lucky to live in a day and age where life-threatening heart conditions like slow heartbeats, rapid heartbeats, and irregular heartbeats can be managed long-term by defibrillators, pacemakers, and resynchronization devices. However, when these devices fail, our health and our hearts fail with them. For this reason, it is absolutely imperative that these devices are as functional and safe as possible.
Unfortunately, some medical device manufacturing companies do not follow the rules when developing, testing, marketing, or recalling their products. This can lead to great harm, and, in some cases, death.
If you or a loved one has suffered harm due to a malfunctioning St. Jude Implantable Cardioverter-Defibrillators (ICD) or a St. Jude Cardiac Resynchronization Therapy Devices (CRT-D), you may wish to speak with a knowledgeable defective medical device attorney about the details of your case.
Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Devices are both small devices that are implanted into the chest and that work to ensure that the heart beats at a normal and regular rate. Those with these devices often suffer from bradycardia (slow heartbeat), tachycardia (rapid heartbeat), or arrhythmia (irregular heartbeat).
In a normally functioning device, an irregularly beating heart will receive a slight “shock” from insulated wires that travel from the device to the heart, returning the organ to its normal pulse. A few months before the battery powering the device is drained, it will vibrate and/or make a noise, alerting the patient that his or her device must be charged or replaced.
Certain types of St. Jude implanted heart devices have been found to malfunction, putting heart patients into harm’s way. Specifically, certain devices suffer from a defective lithium battery in which deposits of lithium within the battery cluster and cause the device to short. The shorted battery means that the device will suddenly, or with very little notice, lose its charge, rendering the device useless. The two affected devices are:
The defective devices were recalled by the FDA in October 2016. The models recalled included the Fortify, Unify, and Assura devices manufactured from January 2010 to May 2015 and used between February 2010 to October 2016. All in all, a quarter million devices were recalled in the United States.
Patients with defected St. Judge heart implantation devices reported a wide range of injuries, including:
In at least two cases, the battery failure has resulted in a patient death, according to the FDA. At least 47 others experienced symptoms like dizziness or fainting when their devices shorted out suddenly, leaving them without a defibrillator.
The FDA also issued the following recommendations to doctors, patients, and caregivers:
The Star Tribune reported that even when St. Jude Medical discovered that their lithium batteries had a chance of sudden failure, and even when they fixed the problem, they still shipped out defective units of the device. In fact, executives at St. Jude admitted that they shipped bad lithium batteries for 17 months after the problem was discovered, putting thousands of patients at risk for a suddenly-malfunctioning pacemakers.
If you or a loved one suffered a serious health problem because of an implanted heart device battery issue, you may deserve compensation for damages, including but not limited to:
To learn more about your case, share your defibrillator story, and learn about your legal options, we encourage you to set up an appointment to speak with one of our knowledgeable attorneys. We offer complimentary, confidential sessions to the victims of St. Jude implantable devices. Call now to schedule: (617) 391-9001.