Company Recalls Dangerous Implantable Cardiac Defibrillators
The U.S. Food and Drug Administration (FDA) and medical device manufacturer Medtronic have announced a major recall of nearly 50 different models of Medtronic’s cardiac rhythm management devices. The recall applies to implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). Medtronic began notifying physicians about a potential problem with devices in January, and a Class I recall soon followed.What are Defibrillator Devices?
According to news sources, the recall affects 48 specific models, each of which is either an ICD or a CRT-D. An implantable cardioverter defibrillator is an electronic device that is implanted under the skin of a cardiac patient to monitor the heart rate. The device is connected to the heart with up to two wires—one in the right ventricle and the other, if necessary, in the right atrium. If the ICD detects an abnormal rhythm, it delivers an electric shock to re-establish a normal heartbeat.
A cardiac resynchronization therapy defibrillator is similar to an ICD, but it adds a third wire lead that goes into the left ventricle. When an irregular rhythm, tachycardia, or fibrillation is detected, an electrical impulse is delivered to both sides of the heart at the same time. Medtronic reports that about 650,000 Americans currently have implanted ICDs or CRT-Ds.The Danger
Reports indicate that the investigation that led to the recall was prompted by a single case in which a device failed and the patient required external defibrillation. The company told doctors in a letter that the devices had undergone “a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality.” In other words, the defibrillators might simply fail to work when needed due to a manufacturing problem.
The recall included devices manufactured between July 2013 and Augusts 2017, but the exact number of affected patients is currently unclear. Medtronic has encouraged doctors to replace the recalled devices as a preventive measure. Replacing an implanted defibrillator device requires a surgical procedure.Protecting the Rights of Patients
In this particular instance, the manufacturer seems to have stayed ahead of potentially life-threatening problems, but that is not always the case. There are countless examples of defective medical products that caused serious issues for affected patients, including artificial hip and knee joints, drug-coated stents, and many others.
If you or a loved one has been injured by a dangerous or defective medical device, contact an experienced San Jose product liability attorney. We will meet with you to review your case and help you explore all of your available options. Call (408) 289-1417 for a free consultation at Corsiglia McMahon & Allard, L.L.P. today.Sources