Pacemaker-Associated Infections Lead to Recurrent Pulmonary Embolisms in 39-Year-Old Man: Study

Doctors call for better diagnostic testing to detect pacemaker infections, which can cause blood clots that travel to the heart and lungs.

A recent case study published in the Annals of Internal Medicine Clinical Cases highlights the role pacemaker infections may play in causing pulmonary blood clots, after doctors traced a patient’s recurring clots in the lungs to his implanted cardiac device.

Pacemakers are small implantable medical devices designed to help regulate abnormal heart rhythms by delivering electrical impulses that prompt the heart to beat at a normal rate. The devices are typically placed under the skin in the chest and connected to the heart through thin wires, known as leads, which monitor heart activity and deliver stimulation when needed.

The devices are widely used in the United States, with about 200,000 implanted each year and an estimated 3 million Americans currently living with a pacemaker.

Pacemaker Concerns

Although pacemakers are widely used and often lifesaving, recent recalls, safety alerts and research findings have raised concerns about potential device malfunctions and infection risks associated with the implants.

A recall of Boston Scientific pacemakers was issued in December 2024 following two patient deaths that were linked to the devices malfunctioning from battery defects. Later, the recall was upgraded to a Class I designation, the most serious type of recall, following hundreds of injuries linked to the problem.

Boston Scientific was also involved in another pacemaker recall in October 2025 affecting more than 55,000 Accolade devices, after battery defects were found to reduce device performance and function, placing patients at risk of serious complications.

Research published last year concluded many individuals who have pacemakers or other implanted medical devices develop bacterial staph infections. Specifically, about 60% of infections associated with pacemakers are caused by Staphylococcus aureus.

Defective device designs, recalls and infection risks have led to a growing number of pacemaker lawsuits against manufacturers in recent years. Boston Scientific has been named in several claims alleging that recalled devices malfunctioned and caused life threatening medical emergencies. Many of the lawsuits indicate patients were forced to undergo additional surgery to repair or replace the implanted device.

In this latest report, a team of researchers, led by Dr. William Salibe-Filho at the University of São Paulo in Brazil, detailed the case of a 39-year-old man with a pacemaker who developed recurring pulmonary embolisms, which are dangerous blood clots that block arteries in the lungs.

The patient originally received the pacemaker in 2006, and the device battery was replaced in 2023 while the original leads remained in place. Shortly after taking a three-hour flight, he began experiencing shortness of breath and swelling in his legs, and a CT scan confirmed a pulmonary embolism.

Doctors initially prescribed the anticoagulant Xarelto, followed by warfarin and a third blood-thinning medication. However, the patient continued to suffer recurring pulmonary embolisms despite months of treatment.

After eight months without improvement, he was referred to a national center specializing in chronic thromboembolic pulmonary disease. Physicians then noticed that each episode was preceded by fever, fatigue, chest pain and shortness of breath, raising concerns that an infection may be triggering the clots.

Further testing suggested the presence of a low-grade inflammatory sepsis infection. During surgery, doctors discovered that a segment of the pacemaker lead had become firmly attached to a heart valve. Surgeons removed the lead and repaired the valve.

Physicians concluded that the pacemaker lead was likely the source of the infection that repeatedly triggered the blood clots. The patient was then treated with antibiotics for several weeks before and after surgery to eliminate the infection.

Researchers said recurring pulmonary embolisms while on anticoagulants is highly uncommon, only occurring in roughly two cases per 100 patient years. There is typically an underlying cause, often cancer. However, in this case, it was an infection caused by the leads of the pacemaker, the researchers determined.

They called for improved diagnostic testing for those with pacemakers to better detect infections.

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