The St. Jude Defibrillator and Therapy Device has been recalled by St. Jude itself due to the serious injuries that can result from their failure to work properly. You may be entitled to compensation for medical bills, lost income and pain and suffering, among other losses. Our law firm works with some of the more experienced St. Jude Defibrillator and Therapy Device lawyers in the country and there is no legal fee unless a settlement or award is obtained. Feel free to contact us toll-free 24/7 at 1-800-992-6878 or submit a contact form online for a free legal consultation.
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What is a St. Jude Defibrillator and Therapy Device?
The St. Jude Defibrillator and Therapy Devices are medical devices that are implanted into a patient’s chest to help alleviate heart rhythm disorders. These two devices are known as implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D). Both of these devices are used to help maintain a healthy heartbeat in patients who have conditions such as bradycardia, which is a slowing heartbeat, and tachycardia, which is a dangerous rapidly beating heart. ICD and CRT-D units can also be used to lower the risk of heart failure as well as other cardiac conditions.
Implantable defibrillators are implanted under the skin in the upper chest area and connected to the heart with wires, called leads. These wires deliver the electric shock to pace a slow heart beat and stop a dangerously fast heartbeat. The units are powered by lithium-based batteries, which can create the device to malfunction due to a rapid loss in power. The problems occurs when deposits of lithium within the battery group together and form “lithium clusters.” These deposits cause the batteries to short circuit and rapidly lose power without adequately warning the patient. Once the battery loses power, the devices will not be able to deliver electric shocks to the heart, which could prove fatal.
Timeline of St. Jude Defibrillator and Therapy Device Events
- October, 2016 – Two deaths are reported to have been linked to loss of defibrillation therapy as a result of premature battery depletion.
- October, 2016 – The FDA issues a safety communication regarding the recall of St. Jude Medical ICD and CRT-D devices, providing recommendations for health care providers, patients and caregivers.
- October, 2016 – St. Jude Medical issues an Important Medical Device Advisory notifying doctors and health care providers of the risk of premature battery depletion associated with the company’s ICD and CRT-D devices manufactured before May 2015.
Are There St. Jude Defibrillator and Therapy Device Lawsuits?
There have been several lawsuits filed that deal with injuries pertaining to the ICD and CRT-D devices. One lawsuit, filed by a woman in Florida alleged that after she was implanted with one of the defibrillators made by St. Jude Medical, she suffered significant cardiac related injuries, including sepsis. She ultimately required an invasive surgery to remove the replace the device, which resulted in economic losses for herself and her husband.
What Are Common Injuries Associated With the St. Jude Defibrillator and Therapy Device?
The most common symptoms that have been reported in connection with the faulty devices are:
- Severe shortness of breath
- Chest pain
- Fluttering in the chest
- Uncontrollable perspiration
- Sudden weakness
More serious injuries that can result are:
- Infection at the implant site
- Allergic reaction to medications used during the procedure
- Swelling, bleeding or bruising where the device was implanted
- Damage to the vein where the ICD leads are placed
- Bleeding around the heart, which can be life-threatening
- Blood leakage through the heart valve where the ICD lead is placed
- Collapsed lung
The malfunction of these devices can also lead to the need for revision surgery to remove the defibrillators, subjecting the patient to all the risks of surgery. The most serious side effect associated with the devices is death. So far, two deaths have been associated with the device’s failure to provide the critical shock treatment when needed. Over 841 of these devices have been returned due to battery failure caused by lithium clusters. There are currently 348,852 of the devices known to be affected by the defect actively in use.
Has the St. Jude Defibrillator and Therapy Device Been Recalled?
These devices were officially recalled by St. Jude Medical on October 10, 2016. At that time, St. Jude Medical sent out a letter to affected patients and health care providers informing them of the danger of premature battery depletion. On October 11, 2016, the Food and Drug Administration (FDA) issued a Safety Communication alerting all those effected of the dangers of the faulty devices. The recall has been classified as Class I by the FDA. This is the most serious type of recall as it means that the device can cause serious injury or death.
What Are the Affected Devices That Have Been Recalled?
According to the FDA recall notice, the following models have been added to the list of recalled defibrillator and therapy devices. They include:
- Fortify VR: Model No(s). CD1231-40, CD1231-40Q
- Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
- Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
- Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR: Model No(s). CD2231-40, CD2231-40Q
- Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
- Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
- Unify: Model No(s). CD3231-40, CD3231-40Q
- Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
- Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
- Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
Contact a St. Jude Defibrillator and Therapy Device Recall Lawyer
If you or a loved one has suffered because of the St. Jude Defibrillator and Therapy Device, then you may want to talk to a personal injury attorney. You may be entitled to damages for your medical bills, lost income, pain and suffering, or other injuries. Our law firm works with experienced St. Jude Defibrillator and Therapy Device recall lawyers, who are now filing St. Jude Defibrillator and Therapy Device lawsuits. And, there are no attorneys’ fees until you receive a settlement or award. Please call us at 1-800-992-6878 or fill out an online contact form in confidence.