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…)

A new type of implantable defibrillator could become the latest target of computer hackers.  In recent years, over 100,000 patients in the US have been implanted with a defibrillator device that has helped to reduce medical visits.  The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor.  Transmissions generally occur once daily.  Now, this relatively common defibrillator monitoring technology appears to be vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock, according to research being released today.

Defibrillator transmissions sent to the bedside monitor are not encrypted, meaning that someone intercepting transmissions could retrieve data such as a patient’s birth date, medical ID, and Social Security number.  Researchers are concerned that as this technology is used in more devices—pacemakers, spinal cord stimulators, and hearing implants—and as radio ranges increase, patients’ data will be at greater risk.  “There will be more implanted devices and more wireless capabilities and transmissions over greater distances,” said Dr. William Maisel, a study authors and Harvard-affiliated director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston. (more…)

The Medtronic Sprint Fidelis Lead debacle highlights many of the shortcomings that exist in the way the Food & Drug Administration (FDA) regulates medical devices, according to a recent editorial in the New England Journal of Medicine (NEJM).  Medtronic recalled its Sprint Fidelis Lead last October, after it was determined that the lead had a high rate of fracturing.

Medtronic suspended sales of the Sprint Fidelis Leads in October, 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 were told to leave the defective components in place unless they fracture. (more…)

Medical device maker Medtronic Inc. said on Tuesday that a proposed bill aimed at curbing inappropriate relationships between companies and physicians should require all device makers to be included, not just big ones.  The proposed “Sunshine Act” was introduced earlier this year by Senators Chuck Grassley and Herb Kohl and would require companies to publicly disclose—via the Internet—certain payments made to physicians for help with product development, research, and training.  Currently, the bill excludes companies with an annual revenue of less than $100 million as well as physician-owned companies, which Medtronic claims accounts for 75 percent of the companies in the medical device industry.  Medtronic said “a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well.”

Recently, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this must change.  The team also found that once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals’ awareness of “the potential promise and pitfalls of new technology.” (more…)

Medtronic Inc.’s profits are off sharply, in part because of problems the company has had with its defective implantable defibrillators. Medtronic’s  third-quarter earnings plunged 89.0% from the prior year on charges from lawsuit settlements stemming from defective defibrillators and acquisition costs.

According to Forbes.com, overall sales at Medtronic  jumped 12.0% to $3.4 billion, up from $3.1 billion in the third quarter of 2006, due to strong international sales. But because of lawsuit settlements and other charges, Medtronic’s net income for the third quarter fell to of $77.0 million, or 7 cents per share, down from $710 million, or 61 cents per share, in the prior year. (more…)

Medtronic Inc. and other medical device makers got a gift from the US Supreme Court yesterday, after it ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits.  While the Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.

According to The New York Times, the Supreme Court’s decision was one sought by the Bush Administration, which since 2004 has been trying to reverse longstanding federal policy  that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law.  In the case considered by the Supreme Court, Medtronic 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…)

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, has asked the US Supreme Court to shield it and other medical devices makers from state product liability lawsuits.  In Reigel vs. Medtronic, the medical device maker argued before the Supreme Court on December 4 that the mere fact that medical devices are approved by the Food & Drug Administration (FDA) preempts patients from bring lawsuits in state courts if they are injured by a defective device.  If Medtronic somehow convinces the court to ban such lawsuits, consumers will lose an important protection against defective medical devices.

Medtronic vs. Reigel stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval.  The case was thrown out by a US District Court judge and then by the US Court of Appeals.   The family is now appealing to the US Supreme Court.

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