Personal Injury Law Firm Filing Claims Against Medtronic Cardiac Defibrillator
How You May Receive Compensation for Your Medtronic Cardiac Defibrillator Injury
At Parker Waichman LLP, our Defective Medical Device Lawyers are evaluating potential Medtronic Cardiac Defibrillator Lawsuits. If you have sustained injuries after having a Medtronic cardiac defibrillator implanted, or used a cardiac defibrillator in a hospital, you may be entitled to compensation. To find out more, it is crucial to discuss your situation with a member of our legal team.
Medtronic Faces Class I Recall of Certain Cardiac Defibrillator Medical Devices
Medical devices can be life-saving for many patients, especially those that address underlying and potentially fatal heart conditions. However, when medical devices fail, patients are at risk of suffering unnecessary injuries and death. The U.S. Food and Drug Administration (FDA) monitors reports of adverse events associated with drugs and medical devices. When the FDA believes a product poses a risk of injury or death to patients, the agency will issue safety notifications and/or recalls.
A Class I recall issued earlier this year by the U.S. Food and Drug Administration involving certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) (collectively referred to as “cardiac defibrillators”) has shed light on a serious manufacturing defect that could mean the difference between life and death. The FDA only issues Class I recalls when a medical device or pharmaceutical drug has the potential to cause severe injuries or death. The reason identified for the Class I recall is that a manufacturing defect “causes an out of specification gas mixture inside the [defibrillator] and may prevent the [defibrillator] from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.”
2023 Medtronic Recall: Urgent Action Required for Implantable Heart Devices
July 21, 2023– Medtronic, a leading medical device manufacturer, has issued a Class I recall for specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These devices were distributed in the United States between October 2017 and June 2023. The recall is prompted by a risk of low or no energy output during high voltage therapy, which can result from inappropriate activation of the Short Circuit Protection (SCP) feature. This malfunction could potentially lead to life-threatening irregular heartbeats and serious harm or death for affected patients.
The recalled products include several ICDs and CRT-Ds, such as Cobalt XT, Cobalt, Crome, Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI, Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava.
As of the recall date, there have been 28 reported incidents related to this issue, resulting in 22 injuries. Immediate action is crucial to prevent further harm.
Medtronic has provided specific actions for patients and healthcare providers to address the recall. Patients should not undergo prophylactic replacement of devices, and healthcare providers must reprogram high voltage therapy pathways and prioritize reprogramming patients with a history of high voltage therapy and specific programmed settings. Regular follow-up and remote monitoring are also recommended.
Affected individuals and healthcare providers are advised to contact Medtronic Technical Services for further information or concerns related to this recall. Understanding the risks and taking the necessary actions promptly can help ensure patient safety and well-being during this critical recall situation.
If you or a loved one have been harmed by one of these recalled Medtronic defibrillators, you or your loved one could be qualified to recover substantial monetary compensation. Call us today to discuss your potential claim.
Medtronic Cardiac Defibrillators Subject to Class I Recall
At Parker Waichman LLP, we believe it is essential that all potential clients are aware of what specific products are subject to a Class I recall. The following information provided on the FDA’s website identifies all Medtronic cardiac defibrillators that were recalled earlier this year due to a substantially dangerous manufacturing defect:
- Products Recalled: Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardiovert Defibrillators (ICDs)
- Product Codes: NIK, LWS
- Serial Numbers: A list of all serial numbers is provided on the FDA’s website
- Manufacturing Dates: July 13, 2013, to August 8, 2017
- Total Number of Devices Recalled in the United States: 48
Medtronic Receives Two FDA Warning Letters as Manufacturing Defects Have Not Been Resolved
The FDA routinely follows up with medical device and pharmaceutical drug manufacturers after issuing Class I recalls to ensure the manufacturers are taking the necessary steps to cure all defects to prevent future injuries and deaths. The FDA recently issued two warning letters to Medtronic, one to the company’s Minnesota location and the other to Puerto Rico, where one of the company’s manufacturing plants is located. The warning letters indicate that, after inspection of Medtronic’s facilities, the medical device manufacturer has not done enough to cure the defect, and there are still manufacturing “non-conformities.”
The two warning letters to Medtronic reveal that the medical device company is still not in compliance with federal law, and Medtronic must take additional steps to cure the manufacturing defect that caused some of the company’s defibrillators to malfunction and fail. The FDA’s warning letters indicate that certain Medtronic defibrillators may still pose a risk of injury and death to patients. Defibrillators are intended to save lives, and when they fail, patients are at risk of suffering heart attacks, cardiac arrest, arrhythmia, and other injuries. Until Medtronic cures the manufacturing defect identified by the FDA’s Class I recall, patients should be cautious, especially those considering the implantable Medtronic defibrillators.
Understanding the Severity of Cardiac Injuries
At Parker Waichman LLP, we represent numerous clients who have suffered cardiac injuries because of defective products. Common cardiac injuries that affect many of our clients include heart attack, cardiac arrest, and arrhythmia. Additionally, many cardiac events can lead to stroke, another debilitating and potentially fatal injury. Cardiac injuries cause not only physical pain and suffering but also take a significant mental and financial toll both on the injured person as well as his or her loved ones. As such, at Parker Waichman LLP, we fight to ensure we are doing everything we can to help injured victims receive compensation for their pain and suffering.
Frequently Asked Questions About Medtronic Cardiac Defibrillator Lawsuits
How Do I Know if I Have Grounds to File a Lawsuit?
The first step to finding out if you have grounds to file a lawsuit is speaking with one of our lawyers right away. During this conversation, you will discuss whether you used a Medtronic defibrillator (perhaps in the hospital setting if there was a need to resuscitate) or one of Medtronic’s implantable defibrillators subject to the Class I recall. You will also discuss the types of injuries you sustained, when you suffered those injuries, and whether you are still suffering from those injuries. Our legal team will also want to know when you suffered your injuries and where you suffered your injuries. After evaluation of the facts of your case, our legal team may wish to obtain medical records to confirm documentation of your injuries. After a review of medical records, our attorneys will determine whether there are grounds to file a lawsuit.
What Should I Do if I Believe I Have Grounds to File a Lawsuit?
It is crucial to act quickly to speak with a Medical Device Lawyer the second you become aware that you may have a lawsuit. Time limitations can prevent some individuals from filing lawsuits, so the sooner you act to have your case reviewed by a member of our legal team, the sooner we can determine if there is still time to pursue legal action. For example, if you suffered a cardiac injury from a defective Medtronic defibrillator and you wait two years to contact a lawyer, it may be too late to file a lawsuit. All states have laws regarding how much time you have to file a lawsuit. As such, the state in which you live or in which you were injured will be the state whose laws apply to your potential lawsuit. One of the biggest reasons why many lawsuits cannot go forward is because the time period for filing a lawsuit has expired. It cannot be stressed enough how essential it is to speak with a lawyer once you learn that you may have grounds to file a lawsuit.
Where Will My Lawsuit Be Filed?
If the Defective Medical Device Lawyers of Parker Waichman LLP determine that you have grounds to file a lawsuit, they may file your lawsuit in state court or federal court. Because many defective medical device lawsuits involve hundreds if not thousands of injured plaintiffs, some cases will be filed in a designated state or federal court that may not be the state where you live or where you were injured. However, traditionally, if the defendant in your case is from your state, your case will be filed in state court. If the defendant in your case is from another state that is different from the state you lived in and/or were injured, then the case will likely be filed in the federal court closest to where you live and/or were injured. For example, if you were injured in New York City, and the defendant in your case is from another state, your case may be filed in the United States District Court for the Southern District of New York. At Parker Waichman LLP, we will ensure you have a good understanding of where your case will be filed after we speak with you and decide to move forward with filing a lawsuit.
How Much Will My Lawsuit Cost Me?
All lawsuits cost money, but some cost much more than others. If you have a potential Medtronic Cardiac Defibrillator Lawsuit, and you decide to move forward with pursuing legal action, you should expect to incur the following expenses:
- Costs to obtain medical records;
- Court filing fees;
- Expert witness fees;
- Deposition fees; and
- Attorneys’ fees.
However, at Parker Waichman LLP, we will not recover any expenses or earn any fees unless you win your case. If your Medtronic Cardiac Defibrillator case does not reach a settlement or you lose at trial, you will not owe us a penny. If your case is successful, our firm will recover expenses and fees once the case is finalized. You will never have to write our firm a check for any case expense during the entire process from start to finish.
How Much Money Will I Receive from My Lawsuit?
It is difficult to estimate how much compensation you may receive for your potential Medtronic Cardiac Defibrillator Lawsuit. Often, the amount of compensation an injured person receives will be dependent on the severity of injuries and how much an injured person has incurred in medical expenses and lost wages. The greater the amount of damages, the greater the amount the compensation is likely to be. However, because all lawsuits are unpredictable, it is impossible to guarantee an injured person that he or she will receive a certain amount in compensation.
Parker Waichman LLP – Obtaining in Excess of $2 Billion for Injured Victims
At Parker Waichman LLP, our legal team has recovered more than $2 billion in compensation collectively for injured clients from all across the United States. While it is impossible to guarantee positive case results, our firm has the resources, skill, and dedication to give clients the best possible chance to receive compensation. Because of our success in helping so many injured and deceased victims, we have received the following peer-reviewed ratings:
- 9.8/10 Rating by AVVO (Rating Every Attorney in the U.S.);
- “Preeminent Lawyers” AV Peer Review Rating (Martindale-Hubbell®);
- Highest Ranking of “5 Dragons” Based on Peer Review by Lawdragon; and
- Listing in Best Lawyers Publication Determined by Extensive Peer Review.
At Parker Waichman LLP, we encourage all potential clients affected by Medtronic’s cardiac defibrillators to contact us to find out how we have been able to obtain compensation for so many clients.
.svg){kind=small}
.avif)
.avif)