PARKER WAICHMAN LLP – MEDTRONIC CARDIAC DEFIBRILLATOR LAWSUIT LAWYERS
In January 2018, Medtronic, a well-known medical device manufacturer, was forced to recall certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) (collectively referred to as “cardiac defibrillators”) that posed a serious risk of harm to patients. The Food and Drug Administration (FDA) released a Class I recall which is the most serious type of recall available and one that notifies patients and physicians that a product may cause serious injury or death. According to the FDA Class I recall safety notification, the defibrillator defect “causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.”
The defective nature of these cardiac defibrillators was linked to a manufacturing defect in one of Medtronic’s plants. While Medtronic has taken efforts to cure the defects, the FDA is not satisfied and has taken the position that Medtronic still has manufacturing “non-conformities” that have not effectively addressed and cured the manufacturing defect related to Medtronic’s cardiac defibrillators.
Medtronic Defective Cardiac Defibrillator Class I Recall Information – What You Should Know
Anyone who was implanted with a Medtronic cardiac defibrillator or has used a Medtronic cardiac defibrillator should be aware of what specific devices are subject to the FDA’s Class I recall. The following information should be helpful for patients trying to determine if they have been injured by a Medtronic cardiac defibrillator currently subject to recall.
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
If you believe you were implanted with a defective Medtronic cardiac defibrillator or used a cardiac defibrillator at some point, it is important that you consult with your healthcare provider. If you believe you have suffered injuries because of the Medtronic cardiac defibrillator, you should consider speaking with a qualified Defective Medical Device Lawyer.
FDA Warning Letters Show Medtronic is Not in Compliance with Federal Law
Following the FDA’s Class I recall earlier this year, the FDA followed up with Medtronic by inspecting two of the medical device company’s facilities, one in Minnesota, and the other in Puerto Rico. Based on the site inspections, the FDA found that Medtronic had not done enough to cure the manufacturing defects identified in the Class I recall notice. As such, the FDA sent two “warning letters” to Medtronic both in Minnesota and in Puerto Rico.
The FDA’s warning letters indicate that Medtronic is still not in compliance with FDA regulations, and therefore, their cardiac defibrillators subject to the Class I recall do not meet necessary specifications to ensure the same manufacturing defect does not happen again. While the FDA stated that the warning letters to Medtronic should not impact patients or physicians in any way, the fact that Medtronic has yet to cure the manufacturing defects associated with the medical device company’s cardiac defibrillators is concerning, especially because patient safety may be at risk. Until Medtronic fixes the internal processes and procedures to avoid dangerous manufacturing defects, patients may continue to be at risk as noted in the FDA’s class I recall notice.
The FDA’s current position on Medtronic’s efforts to cure the problems that led to manufacturing defects with many of the medical device company’s cardiac defibrillators is that Medtronic still has work to do to make its products safe and effective for human use. After all, defibrillators can be life-saving medical devices for many patients, and if one small manufacturing defect can render the medical device unsafe, then patients are at risk of suffering serious injuries or death. When medical device companies like Medtronic design, manufacture, and sell life-saving medical devices, they take on the responsibility to ensure the products are safe and free from defects.
Next Steps if You Have a Medtronic Cardiac Defibrillator
If you have been implanted with one of the Medtronic cardiac defibrillators (or used a Medtronic cardiac defibrillator at some point, perhaps in a hospital) subject to the FDA’s Class one recall, you may consider speaking with your physician about whether the product is safe for you. Because all patients are different, a doctor may recommend that one patient simply do nothing and recommend that another patient seek alternative treatment for the underlying heart condition. Given that the manufacturing defect identified in the Class I recall notice involves a key component of the medical device (the failure of the device to transmit an electrical shock), patients are at risk of device failure which could lead to fatal conditions such as heart attack, cardiac arrest, or stroke.
While the FDA has not stated that a patient has died because of a Medtronic cardiac defibrillator subject to the Class I recall, the risk of serious injury or death certainly still exists. Until Medtronic cures the manufacturing defect in accordance with the FDA’s requirements, patients should be cautious when considering a Medtronic cardiac defibrillator to treat an underlying heart condition and should discuss all concerns with their doctors.
Holding Medtronic Accountable – What You Should Know if You Were Injured by a Cardiac Defibrillator
Because Medtronic and other medical device companies have a responsibility to ensure their products are safe and effective for their intended use, any time a patient suffers an injury or death because of a defective product, the medical device company may be held responsible. Pursuing legal action is one way to hold a medical device company responsible when its products cause serious injuries or death to innocent patients. While mistakes do happen, mistakes that can cost a person his or her life at the expense of significant profits are simply not acceptable. After all, medical device companies are supposed to evaluate all potentially dangerous defects that can happen during the design or manufacturing process before putting the medical device on the market.
Medtronic has taken the initial step of recalling affected cardiac defibrillators and is working with the FDA to cure the manufacturing defect that has plagued so many of Medtronic’s cardiac defibrillators. However, there are still patients walking around with recalled cardiac defibrillators who may be wondering whether the defibrillator will work as intended or fail in a way that renders the product useless, and therefore, posing a risk of injury or death. Because so much is on the line, it is essential to work alongside a Defective Medical Device Lawyer who has extensive experience fighting large multi-billion-dollar medical device companies whose primary goal is to earn profits and not necessarily to ensure patient safety.
Contact Parker Waichman LLP Today to Schedule Your Free Consultation
If you have a Medtronic Cardiac Defibrillator and you have suffered injuries you believe to be related to the defibrillator, you should consider how a Defective Medical Device Lawyer can help you. The Medtronic Cardiac Defibrillator Lawsuit Lawyers of Parker Waichman LLP routinely fight large medical device companies who manufacture and sell dangerous and defective drugs and medical devices.
To learn whether you may be entitled to compensation for your injuries, contact a member of our legal team today by calling (800) YOUR-LAWYER (968-7529) to schedule your free consultation.
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