Cardiac devices dominate the list of reports to the Food and Drug Administration of deaths and injuries. Here are three devices that have had significant problems in recent years:
Implantable cardioverter-defibrillators. Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from these devices, by far the most for any device type, according to our analysis of the FDA’s database of adverse events. Implanted in more than a half-million Americans with serious heart disorders, the defibrillators detect abnormal rhythms and administer shocks to correct them.
The most troublesome aspect of the devices are the leads—wires that connect them to the heart. There have been two major recalls, in 2007 and 2011, of defective leads, the Medtronic Sprint Fidelis and the St. Jude Riata, after they had already been implanted in almost 350,000 patients. Patients with the device leads require close monitoring and face the prospect of having to have them surgically removed.
In congressional testimony in 2009, Boston cardiologist William Maisel, M.D., described what happened to a patient of his: “The simple act of removing his shirt over his head caused his … lead to fracture. [He] suffered a cardiac arrest in front of his wife.” The patient survived but never fully recovered.
Vena cava filters. These devices are placed in the vessel that returns blood from the lower body to the heart to prevent pulmonary embolism, a life-threatening condition caused by blood clots breaking loose from the leg and traveling to the lungs. Some 200,000 people get such filters each year.
Many should be removed once the danger of clots has passed, but often aren’t. In a November 2010 study in the Archives of Internal Medicine, Pennsylvania researchers found that pieces of the Bard Recovery filter had broken off and migrated elsewhere in the body in one of four study patients. One patient needed open-heart surgery.
“Remarkably,” wrote cardiologist Rita Redberg, M.D., of the University of California, San Francisco, in an editorial accompanying the report, these filters “were considered Class II by the FDA—the same risk category of mercury thermometers—and received approval without any clinical data of safety and effectiveness.”
“The devices were being used inconsistent with their FDA clearance,” says Jeffrey Shuren, M.D., director of the agency’s Center for Devices and Radiological Health. “We don’t have authority to do something about that.” If you’ve received the device, ask your doctor whether it has been removed.
Automated external defibrillators. Found in airports and other public buildings, these devices are designed so that bystanders can operate them. AEDs automatically diagnose abnormal heart rhythms and deliver shocks to people in cardiac arrest.
The problem is, they don’t always work. The industry has conducted about 90 recalls over the past several years, affecting hundreds of thousands of devices. Between 2009 and 2011, the FDA received reports of 72 injuries, 686 deaths, and 20,667 malfunctions connected with the devices. Arizona researchers found that in most cases the machines weren’t able to diagnose the abnormal rhythms properly or failed to deliver the recommended shock.
The FDA is considering whether to downgrade AEDs from the highest-risk category to moderate-risk. recalled Defibrillators have been recalled 90 times in seven years.