Medtronic Azure Lawsuit Claims Pacemaker Caused Heart Arrhythmias

Lawsuit alleges device failures resulted in chest pain, near-fainting and other adverse symptoms, forcing the patient to undergo additional monitoring and medical costs.

A product liability lawsuit claims that a defective Medtronic Azure pacemaker failed to properly detect and record dangerous heart rhythm abnormalities, leaving a Pennsylvania woman to suffer worsening arrhythmias, repeated medical complications and emotional distress.

The complaint (PDF) was filed by Susan Lloyd in the U.S. District Court for the District of Minnesota on April 27, naming Medtronic Inc. as the defendant.

Lloyd claims she previously relied on older Medtronic pacemakers that functioned properly, yet she began experiencing serious issues after her device was replaced with a Medtronic Azure pacemaker in July 2018. She indicates the newer device failed to record episodes of rapid arrhythmias, even when she experienced significant symptoms.

Pacemaker Risks

Pacemakers are implantable medical devices placed in the chest to regulate irregular heart rhythms by delivering electrical impulses that help maintain a steady heartbeat when it becomes too slow or erratic.

However, when these devices fail or are defectively designed, patients may face serious and potentially life-threatening complications. In recent years, this has led to a growing number of recalls and product liability lawsuits involving pacemakers.

Earlier this year, a Washington woman filed a Boston Scientific pacemaker lawsuit, alleging that a recalled device from that manufacturer malfunctioned more than a decade after implantation, causing a life-threatening emergency that required urgent surgery. 

A separate lawsuit filed a couple weeks earlier, claimed that a Medtronic Azure dual-chamber pacemaker caused abnormal electrical activity and dangerous heart rhythm issues for a Connecticut woman, ultimately requiring surgery to remove and replace the device.

Comparable product defect claims have also been raised in a number of spinal cord stimulator lawsuits against the same manufacturers, Medtronic and Boston Scientific. These devices, which also use electrical signals within the body, have been linked in complaints to alleged design or manufacturing problems that caused patients to experience unexpected shocks, burns and other complications.

Medtronic Pacemaker Malfunction Allegations

Lloyd’s lawsuit alleges that despite repeated complaints and ongoing symptoms, her Azure pacemaker did not properly record abnormal heart rhythms, including episodes of ventricular tachycardia and other rapid arrhythmias that should have been noted by the device.

To evaluate her condition, Lloyd indicates she wore multiple external heart monitors over the past several years, including devices from other manufacturers, which consistently detected frequent arrhythmias that her implanted pacemaker failed to capture.

According to the complaint, Lloyd experienced numerous episodes over short monitoring periods, sometimes more than a dozen arrhythmias within days. However, her pacemaker recorded none of them. The lawsuit claims the device should have been capable of detecting these events, particularly when heart rates exceeded thresholds typically used to identify abnormal rhythms.

Lloyd further alleges that even after physicians lowered the detection threshold the device settings did not increase in sensitivity, and the pacemaker still failed to record the arrhythmias, raising concerns that it was not functioning as designed.

The complaint suggests the failure may be linked to battery or manufacturing defects that interfered with the device’s ability to monitor cardiac activity. Lloyd claims Medtronic representatives acknowledged potential battery-related issues affecting the device’s performance, yet no effective fix was provided.

As a result, the lawsuit indicates Lloyd suffered repeated symptoms, including chest pain, shortness of breath, nausea and near-fainting episodes, as well as emotional distress and frustration over the lack of accurate monitoring. She also underwent additional testing and monitoring, including wearing long-term external devices, which led to skin irritation and increased medical costs.

“Lloyd has suffered actual injuries (delay of treatment of her cardiac arrhythmias, emotional distress at being told once again nothing showed up on Lloyd’s device despite Lloyd having presyncope and other severe symptoms, skin rashes after having to wear multiple monitors, a surgery to implant a recording device, a surgery sooner than should be required to replace Lloyd’s defective device).”

— Susan Lloyd v. Medtronic Inc.

The lawsuit raises allegations of product liability, negligence and fraud, claiming the device was defectively designed and manufactured, and that Medtronic failed to disclose known risks. It seeks damages for physical injuries, emotional distress, medical expenses and other losses.

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