March 1, 2018
Medtronic has announced a recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardioverter Defibrillators due to a manufacturing error that can prevent the devices from properly administering a shock.
The U.S. Food and Drug Administration (FDA) announced the recall and noted that it is categorized as a Class 1 recall. Class 1 recalls involve devices whose use may cause serious injuries or death.
What are Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?
According to the FDA, both devices are implanted under the patient’s skin into the upper chest. They contain wires (known as leads) that are connected to the patient’s heart. The devices are used to regulate the heart rate, including providing pacing for a heartbeat that is too slow (bradycardia) and providing pacing or electrical shock if the heart rate is too fast (tachycardia). Both devices can also be used to treat heart failure.
Why Did Medtronic Issue the Recall?
On January 22, 2018, Medtronic issued an Urgent Medical Device Recall notice regarding its Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators. That notice was sent after the company received reports that a manufacturing defect could cause an “out of specification gas mixture inside the device.” That gas mixture could potentially prevent the devices from delivering a life-saving electrical shock to pace the patient’s heartbeat.
Without that shock, the patient could suffer serious harm, including death.
In its Urgent Medical Device Recall notice, Medtronic urged customers to consider replacing the devices in patients who had them implanted. The company also noted that it does not know when the devices will fail or how many charges they will supply before failing, but that the failure could be permanent. At least one patient suffered device failure but received external defibrillation and survived.
The device maker offered a supplemental device warranty for customers affected by the recall. Included in the recall were certain models of the Amplia, Claria, Compia, and Viva Cardiac Resynchronization Therapy with Defibrillation devices and certain models of the Evera and Visia Implantable Cardioverter-Defibrillators.
All 48 recalled devices were manufactured between July 13, 2013, and August 8, 2017.
Patients May Require Revision Surgery
The dozens of patients who received the Medtronic defibrillators may require revision surgery to remove the faulty devices and replace them with new ones. Revision surgery comes with its own complications and risks.
Medical Device Recalls All Too Common
Patients rely on medical devices to provide life-saving treatment, but all too often these devices are the subject of Class I recalls, in which patients’ life and health could be at risk. Medical device manufacturers are responsible for ensuring their products work as intended, are safe, and are manufactured properly to avoid harm to patients.
When manufacturers fail in their responsibility, the consequences can be catastrophic for patients.
Medtronic itself has been the subject of numerous recalls and lawsuits. Patients filed a lawsuit against the device maker regarding its Infuse Bone Graft. The lawsuits alleged the Bone Graft was linked to severe side effects, such as nerve damage, paralysis, and excessive bone growth.
A series of reports in 2011 in the Spine Journal suggested that Medtronic gave misleading information regarding the risk of side effects in its Infuse Bone Graft.
Among the allegations against Medtronic regarding the Infuse Bone Graft are medical negligence, failure to warn, and manufacturing a defective product.
If you or a loved one has been harmed by a medical device failure, including the Medtronic defibrillator, you may be eligible to file a lawsuit against the people or parties responsible. Our experienced attorneys can help you determine the best course of action and can explain your rights and options.
We are committed to helping you obtain justice against negligent medical device manufacturers who put profits above patient safety. That means going the extra mile to ensure your case is as strong as possible, and as a result, we’ve obtained hundreds of millions of dollars for our clients.
You need a personal injury attorney who is experienced at taking on large medical device manufacturers. Attorneys at Cutter Law have been involved in litigation against many large medical device manufacturers. Brooks Cutter was appointed to the Plaintiff’s Steering committee in another case against Medtronic, this one involving the Sprint Fidelis. That case ultimately settled for more than $220 million.
Contact a medical device failure lawyer at Cutter Law today to discuss your situation.