Medtronic Pacemaker Lawsuit Claims Man Died as Result of Defective Device

Lawsuit alleges Medtronic disregarded known extraction risks associated with Attain StarFix leads used in certain pacemaker systems, despite evidence of removal complications.

A man’s lawsuit argues that StarFix leads in his father’s Medtronic pacemaker did not detach properly during removal surgery, tearing a vein in the patient’s heart, which resulted in brain damage and death.

The complaint (PDF) was originally filed on October 30 in Oklahoma District Court by Jacob Koontz, acting as personal representative for the estate of his late father, Jeffery Koontz. Medtronic Inc. later removed the case to federal court, transferring it to U.S. District Court last month based on diversity jurisdiction.

Pacemakers are medical devices implanted under the skin to help regulate abnormal heart rhythms, delivering small electrical pulses to keep the heart’s chambers beating in sync. They are commonly used to treat fast, slow or irregular rhythms, and can also support patients at risk of heart failure by improving the heart’s ability to pump blood and circulate oxygen.

Although pacemakers are generally considered safe, a series of recalls in recent years has raised concerns about certain Medtronic models. In 2015, a Medtronic InSync III pacemaker recall was linked to at least one death after more than 30 confirmed reports of battery malfunctions. Earlier recalls involving Medtronic Kappa and Sigma devices were tied to defective wiring, which was associated with at least two additional deaths.

According to the lawsuit, the pacemaker system implanted in Jeffery Koontz included Medtronic’s Attain StarFix left ventricular lead, which uses plastic fixation lobes intended to anchor the lead inside the coronary veins. 

The lawsuit indicates that Koontz underwent lead extraction surgery in November 2023 at Oklahoma Heart Hospital South. However, the fixation lobes failed to retract as designed. Surgeons attempted to remove the lead using advanced extraction tools, including a laser sheath, yet the stuck lobes allegedly tore the coronary sinus and triggered cardiac tamponade, requiring emergency open-heart repair.

Cardiac tamponade is a medical emergency in which blood or fluid rapidly accumulates in the sac surrounding the heart, preventing it from expanding and pumping properly. If not treated immediately, the condition can lead to shock and organ failure.

Koontz suffered 25 to 30 minutes of oxygen deprivation during the emergency response, resulting in brain damage, cognitive impairment and other complications, according to the filing. He remained hospitalized and underwent additional procedures before dying in July 2025. The lawsuit claims the risks posed by the StarFix lead were not discoverable until the extraction attempt failed.

“The non-retractable lobes of the StarFix Lead ultimately caused a coronary sinus tear resulting in cardiac tamponade that required emergency surgical repair via sternotomy and cardiopulmonary bypass. Deceased suffered oxygen deprivation for approximately 25-30 minutes, resulting in permanent brain damage, short-term memory loss, and other serious injuries.”

— Jacob Koontz v. Medtronic Inc.

The complaint accuses Medtronic of negligence and product defects, arguing that the company knew or should have known the StarFix design created unusual extraction risks compared to standard leads. It alleges Medtronic failed to test the device adequately, failed to warn physicians and patients, and continued marketing the lead despite clinical data showing higher complication rates during removal.

Koontz’s estate seeks damages exceeding $100,000 for medical expenses, pain and suffering, loss of income, disfigurement and loss of enjoyment of life. The suit also seeks compensation for the family’s grief and loss of companionship, as well as punitive damages based on allegations that Medtronic acted with reckless disregard for patient safety.

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