Dr. Robert Hauser of the Minneapolis Heart Institute Foundation has said in today’s New England Journal of Medicine that he is not confident in the test guidelines for a next-generation heart defibrillator under development by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc., reports the StarTribune.com.

Implantable cardioverter defibrillators—or ICDs—the device under question, represent a $5 million dollar market, with over 160,000 such devices implanted each year in the U.S., said the StarTribune.com, which explained that the devices are about the size of a stopwatch and work to stop sudden cardiac arrest by shocking the heart back into rhythm.  One ICD device runs about $30,000 said TwinCities.com. (more…)

A new study has revealed that some headphones can interfere with implanted heart devices such as pacemakers or defibrillators, when the headphones and the devices are in close proximity, such as when the headphones are in a shirt pocket or when they are draped around the neck.  And, the interference can also occur when the headphones are disconnected.

The headphones might even prevent a defibrillator from delivering a lifesaving shock, say the doctors involved in the study.  “Headphones contain magnets, and some of these magnets are powerful,” said the study’s leader, Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, Massachusetts.  Dr. Maisel is also a heart device consultant to the federal Food and Drug Administration (FDA).  “It’s smart to keep small electronics at least a few inches from implanted medical devices, and not let someone wearing headphones lean against your chest if you have one,” he said.  “The headphone interaction applies whether or not the headphones are plugged in to the music player and whether or not the music player is on or off,” Dr. Maisel noted. (more…)

Medtronic Inc. is recalling some of its portable Lifepak Automated External Heart Defibrillators because the button that activates the device is inaccessible.  The Food & Drug Administration (FDA) classified the action as a Class 1 recall, meaning there is “a reasonable probability” of “serious adverse health consequences or death.”

The recall involves 249 LifePak CR Plus Automated External Defibrillator with Product Number: 3200731-003 and 3200731-027.  The defibrillators were manufactured by Medtronic’s Physio Control unit between May 20, 2004 through August 11, 2007 and distributed from May 20, 2004 through December 4, 2007. (more…)

Medtronic has received approval from federal regulators for a software update to its implantable defibrillators that will help detect fractures (breaks) in their lead wires. The Food & Drug Administration (FDA) approval of the software update comes nearly one year after Medtronic recalled its Sprint Fidelis defibrillator lead wires because of their high fracture rate.

A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. (more…)

While a defibrillator shock may provide a lifesaving nudge, the Associated Press reports that such a shock from an implanted heart defibrillator may also be linked to future problems and early death.  The government-funded study revealed that heart failure patients were far more likely to die within four years following defibrillator activity than patients who were not shocked.

Experts urge patients to immediately advise their doctors if they experience defibrillator triggering.  Likewise, doctors are urged to review their patients’ condition to determine if the condition has worsened and if tests or medication changes are required.  “We need to think about everything else we possibly could do to make them as healthy as they can be,” said the study’s lead author, Dr. Jeanne Poole of the University of Washington.  The study’s findings appear in today’s New England Journal of Medicine. (more…)

A Pennsylvania woman went to Capitol Hill yesterday to ask lawmakers to overturn a Supreme Court  ruling that has stripped consumers of their right to sue for injuries caused by defective medical devices.    Bridget Robb was shocked more than two dozen times due to a defective Sprint Fidelis Lead attached to a Medtronic implantable defibrillator.  Because the Supreme Court has taken away her right to sue the company, Robb said she was forced to go to Congress for justice.

Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits.  In February, medical device makers got their wish when the Supreme Court ruled that that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts.   Medtronic, which had brought the case before the Supreme Court,  and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. (more…)

It seems that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, this according to two new surveys.  Although the surveys are small, they do indicate a lack of understanding among doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic Wilkoff, who is familiar with the surveys. “There are fundamental problems with even the physician’s understanding of the situation and an appropriate focus on accurate information,” Wilkoff added.  One of the new surveys found that nearly one in five heart patients didn’t know about recent recalls of their devices.

Meanwhile, recent recalls of implanted defibrillators have forced some patients to have them removed.  Spefically, defibrillator lead wires—especially those in the Medtronic Sprint Fidelis and St. Jude Riata devices—have fractured, perforated patient heart walls, or caused device failure.  In some, these malfunctions led to additional cardiac procedures or complications and even death.  Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops.  A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator.  When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock.  If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively.  Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall. (more…)

Still struggling in the wake of last year’s Sprint Fidelis Defibrillator Lead recall, medical device maker Medtronic Inc. says it plans to cut 1,100 jobs worldwide as part of a restructuring plan.  Medtronic’s business has been hurt, not just by the Sprint Fidelis recall, but by the declining worldwide demand for implantable defibrillators, which has been shrinking since Medtronic and competitors recalled faulty products in 2005.

Medtronic suspended sales of the Sprint Fidelis Leads in October 2007 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture. (more…)

Cardiac-resynchronization therapy (CRT) devices don’t do much for patients with mild heart failure, according to a just completed clinical trial.  The clinical trial, called REVERSE, was funded by Medtronic Inc. in the hope that it could expand the market for its CRT devices to patients with mild heart failure.  As it stands now, CRT devices are only approved for people with severe heart failure.

About 5 million Americans have hearts so weak they don’t pump enough oxygen-rich blood to fuel the body. CRT devices are typically implanted in patients diagnosed with severe heart failure, where the heart cannot pump enough blood through the body. CRTs are often designed to provide shocks when hearts get dangerously out of control. Such devices are known as CRT-Ds, as they also have a defibrillator function. They cost around $32,000, more than a typical high-end defibrillator. (more…)

Lawmakers in Congress are getting closer to passing legislation that would overturn a Supreme Court decision that barred people injured by defective medical devices from suing in state courts if the device was approved by the Food & Drug Administration (FDA).  Two members of the House of Representatives say they are drafting a bill to overturn the decision that should be ready sometime next month.

In the case considered by the Supreme Court, Medtronic Inc, the maker of the faulty Sprint Fidelis Defibrillator Lead and other defective devices,  had argued  that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts.  That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims.  Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws. (more…)