Medtronic CapSureFix Pacemaker Lawsuit Claims Device Failed and Could Not Be Safely Removed

Plaintiff seeks $50 million in damages over claims that Medtronic’s CapSureFix pacemaker lead failed and became embedded in scar tissue, leaving him unable to safely have the device removed.

A Kansas man has filed a lawsuit against Medtronic, alleging his CapSureFix pacemaker lead failed after nearly 13 years, and had become so embedded in scar tissue that doctors determined it could not be safely removed.

The complaint (PDF) was brought by Caleb Boone in Missouri Circuit Court on May 4, naming Medtronic Inc. as the sole defendant. The case was removed to the U.S. District Court for the Western District of Missouri on July 2.

Boone claims Medtronic knew its CapSureFix leads could prematurely fail and become permanently trapped inside patients’ bodies, yet failed to adequately warn doctors and consumers about the potential risks.

This problem can allegedly leave patients with malfunctioning pacemaker leads that cannot be removed without creating a substantial risk of catastrophic bleeding, cardiac injuries or death.

CapSureFix Pacemaker Lead Problems

Pacemaker leads are thin, insulated wires that connect an implanted cardiac device to the heart, allowing electrical impulses to help regulate a patient’s heartbeat.

Boone indicates he received a Medtronic pacemaker and two CapSureFix MRI leads during surgery at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, on May 2, 2011.

The leads remained implanted when Boone’s original pacemaker was replaced with another Medtronic device in June 2022, at which time they were disconnected from the old device and connected to the replacement pacemaker.

However, Boone claims one of the CapSureFix leads was discovered to be defective and malfunctioning on April 1, 2024.

CapSureFix Lead Failure Injury Allegations

According to the lawsuit, doctors evaluated whether the failed lead could be removed during surgery on August 22, 2024. However, they determined it had become trapped by scar tissue and that attempting to extract it created an unacceptably high risk of catastrophic and potentially fatal bleeding.

As a result, the failed lead and existing pacemaker were left in place on the left side of Boone’s chest. The following day, doctors implanted another pacemaker and new leads on the right side of his chest.

Boone claims scar tissue can form around the leads over time, potentially requiring doctors to use specialized extraction equipment that carries a risk of coronary sinus tears, cardiac tamponade, catastrophic bleeding and emergency surgery.

Despite those risks, the lawsuit alleges Medtronic continued to market the CapSureFix leads without adequately warning doctors or patients about the potential for premature failure and serious extraction complications.

“Following implantation, the Capsurefix Lead remained in the Petitioner’s body for twelve years and eleven months, functioning as part of his CRT system. During this time, scar tissue formed around the lead—a natural biological response that Medtronic knew or should have known would make safe extraction increasingly difficult or impossible.”

— Caleb Boone v. Medtronic Inc.

Boone also claims Medtronic failed to adequately test the devices, properly investigate reports of extraction problems and update the product warnings as new safety information became available.

The filing maintains the problems with the Medtronic CapSureFix lead forced Boone to undergo unnecessary surgeries on both sides of his chest, resulting in physical injuries, pain, mental anguish and financial losses.

Several weeks after the procedures, Boone claims he fell while getting into a car and fractured his right hip.

The lawsuit alleges the fall was caused by muscle damage, reduced dexterity and impaired reflexes resulting from the additional surgeries required after the CapSureFix lead failed and could not be removed.

The complaint raises allegations of negligent manufacture, design and engineering, in addition to fraud. It seeks relief for pain, suffering, mental anguish and disfigurement in the amount of $50 million, as well as compensation for economic losses and other damages.

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