How to Obtain Full Compensation for Injuries, Heart Attacks, & Wrongful Death Claims Connected with the Boston Scientific EMBLEM S-ICD Electrode Fracture Defect Recall
Parker Waichman LLP is an award-winning national law firm that has recovered over $2 billion in compensation for injured clients and families who lost a loved one due to the defective products.
Parker Waichman offers free consultations and is currently representing claimants in Boston Scientific EMBLEM S-ICD lawsuits throughout the United States. These lawsuits seek to recover compensation for those harmed by an electrode fracture defect that has caused severe complications, including strokes, heart attacks, injuries, brain damage, and fatalities.
The process of recovering compensation for you or your loved one’s EMBLEM S-ICD electrode failure losses begins by contacting Parker Waichman LLP to discuss your legal rights and potential case. Our caring team is ready to listen to you. Call us at 1-800-YOURLAWYER (1-800-968-7529) for a discussion about your situation.
About Subcutaneous Implantable Cardioverter Defibrillators (S-ICD)
What is a Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)?
A subcutaneous implantable cardioverter defibrillator (S-ICD) is a medical device that is implanted inside the chest cavity of a patient who suffers from life-threatening, abnormal heart rhythms. The cardioverter defibrillator constantly monitors the patient’s heart rhythm. When the defibrillator identifies a fast, abnormal heart rhythm, the device sends a small electrical shock to the heart muscle. The electrical shock causes the heart to regain its normal heartbeat rhythm.
S-ICDs are different from traditional ICDs because the leads (ICD wires) that connect the device to the patient’s heart are implanted under the skin rather than through the patient’s veins. This makes replacing the device’s leads much easier and less invasive.
Why Was the Boston Scientific EMBLEM S-ICD System Developed?
The S-ICD System is a unique implantable defibrillator developed by Boston Scientific to treat patients suffering from life-threatening ventricular arrhythmias, also known as ventricular tachycardia and ventricular fibrillation.
According to its creator, Boston Scientific, their S-ICD device is a one of a kind implantable defibrillator. The EMBLEM MRI S-ICD is the only subcutaneous implantable defibrillator on the market that protects patients from “sudden cardiac death, and the complications and risks associated with transvenous leads.” Transvenous leads are wires that connect the defibrillator and the heart by passing the wires through the patient’s veins.
Why is the Boston Scientific Emblem S-ICD Being Recalled?
FDA Issues a Class I Recall of Boston Scientific S-ICDs Due to Reports of Injuries and Deaths
February 2, 2021 – The U.S. Food and Drug Administration (“FDA”) announced the recall of Boston Scientific’s EMBLEM S-ICD Subcutaneous Electrode (Model 3501) due to the risk of electrode fracture causing injuries and deaths. The FDA classified this recall as a Class I recall, which is the FDA’s most serious type of product recall. A Class I recall is issued when a product, drug, or medical device could cause serious injuries or death.
The FDA Identified Severe Injury and Death Complications with the of Boston Scientific Emblem S-ICD System
According to the FDA, Boston Scientific’s Emblem subcutaneous electrode’s fracture defect has caused 26 serious injuries and one death. The death was caused by the patient’s electrode lead fracturing, causing the device to die. Boston Scientific reported that the company had received 27 reports of “electrode body fractures at a location just distal to the proximal sense ring.” As a result of these adverse events, Boston Scientific initiated a recall of its Emblem S-ICD System. The Emblem S-ICD device was classified as a Class I recall by the FDA because the device’s electrodes have a potential to fracture inside the patient, causing the device to fail, leading to injuries, strokes, heart attacks, cardiac arrest, and deaths.
Boston Scientific S-ICDs have been implanted in about 90,000 patients over the past ten years. The company states that the issue of electrode fracture is rare and the company claims the occurrence rate is 0.2% at the 41-month mark.
Boston Scientific has asked physicians to enroll their S-ICD patients in its remote LATITUDE monitoring service, instruct patients to conduct weekly checks, and for doctors to perform a system review with their patients every three months. Boston Scientific believes this process will help to reduce the likelihood that the device’s electrode will fracture, causing harm to their patients.
You May Be Entitled to Receive Compensation for Your Losses
Due to complications caused by defective Boston Scientific Emblem S-ICD electrodes, patients harmed, and people who lost loved ones due to the defect are contacting Parker Waichman to file lawsuits demanding fair and just monetary compensation. Recovering from a cardiac event related to the defective S-ICD electrodes may require surgical intervention, lifestyle changes, therapy, and medications. As a result, those harmed by the recalled device might be able to seek compensation for the following electrode fracture-related damages:
- Counseling or mental health service costs if you find that you are depressed after your incident
- Lost future earnings that are the result of being unable to return to work
- Lost wages due to time missed from work
- Medical bills
- Prescription drug costs
- Therapy and physical rehabilitation costs
- Mental pain and anguish
- Wrongful Death damages
- and other economic and non-economic expenses and losses
Filing a Boston Scientific Emblem S-ICD lawsuit might help you recover financially and recompense you for further medical care expenses. If a defective Boston Scientific Emblem S-ICD has harmed you or a loved one, an attorney from our law firm can help you obtain full compensation.
Why Choose Parker Waichman to Represent You?
Parker Waichman has established a reputation for excellence and litigating cases against large drug companies. You can feel confident that your legal rights are being protected when you retain our firm.
Our recent achievements:
- We have recovered more than $2 billion in verdicts and settlement awards for our clients.
- We have earned the prestigious “AV Preeminent” rating in a peer review by Martindale-Hubbell.
- We have also earned the coveted “5 Dragons” rating by Lawdragon, its highest rating, based upon peer review.
Parker Waichman is ready to listen to you and analyze your potential claim. If we are able to represent you or your loved one, you can rest assured that the same focus, resources, and knowledge that we have used to build our firm’s reputation will be brought to bear on your case.
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