Medtronic Inc.’s Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators.

In March 2009, Medtronic reported that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. Now, The Wall Street Journal is reporting that according to the Food & Drug Administration (FDA) database, 12 additional deaths allegedly linked to the Sprint Fidelis have been reported to the agency since last March

According to The Wall Street Journal, a report from the University of Rochester published in the January issue of the American Journal of Cardiology said the three-year survival rate of 426 Medtronic leads inserted in patients there was 90.8%, meaning 9.2% failed. A report from the Mayo Clinic published last February in the journal HeartRhythm said the estimated rate of failure among 848 leads implanted there after three years of use was 12.1%.

In November, a separate Mayo Clinic study showed the failure rate for Sprint Fidelis leads after two years was 20.4% in patients younger than 50, while the rate in older patients was only 3.5%. Another HeartRhythm study published in October 2008 by the University of Ottawa found the risk of a Sprint Fidelis fracture “increased significantly with time.”

According to a letter sent to doctors,  one of the wiring issues was previously reported in a November 2005 advisory. The 2005 advisory was related to wire separations caused by a particular cleaning solvent used in manufacturing and is not related to a new Kappa/Sigma wire separation issue also discussed in the letter. There are currently an estimated 15,600 active implants from this 2005 Sigma device subset, Medtronic said.

According to a report in The Wall Street Journal, the 2005 advisory told doctors that the issue required “watchful waiting”.   But because the failure rate from this problem is higher than first thought, the company  now recommends that replacement be considered for some patients with Kappa or Sigma pacemakers.  Medtronic  said in its letter that the current risk  of  failure for the Sigma pacemakers affected by this problem is less than 4% over the lifespan of the devices.

A second, and newer separation issue affects an estimated 15,200 active Kappa devices and 6,100 active Sigma devices, manufactured primarily between November 2000 and November 2002.  The Medtronic letter said most of these devices were implanted in patients for five years or longer and may be nearing normal elective replacement time.

Medtronic said it  has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism. Its modeling predicts failure rates of 1.1% for Kappa devices and 4.8% for Sigma over the remaining lifetime of these pacemakers due to this issue.  According to the letter, there is no provocative testing that can predict which specific devices may fail, and no device programming can mitigate this issue if it occurs.

Medtronic said that for most patients, device failure from either of  these issues could result in  slow heart rhythms that would cause lightheadedness or fainting, but not life-threatening complications.  These patients should seek medical attention if they experience these symptoms.

In a small number of patients who do need pacemakers to provide life-saving therapy at all times, however, such an event could prove fatal.  Medtronic’s letter said that in these cases, doctors may want to consider replacing the pacemaker.

Medtronic said it has received reports of  two patient deaths where it is possible, but unclear, whether a wire separation issue may have been a factor.

According to the Associated Press,  the group called on the Food & Drug Administration (FDA) to require that new defibrillator leads be tested in humans before they are approved.  Currently, most leads are approved through the agency’s fast track process, which is reserved for devices that are considered modifications of existing products.  The fast track process does not require human studies.

According to  the Associated Press, the group also said hospitals need to train more doctors to remove faulty defibrillator leads.   They said physicians should perform at least 40 extractions under expert supervision before operating on their own. Supervising physicians should have performed at least 75 extractions with a high rate of success, the group states.  They also recommended that such training take place only medical centers that perform a large number of lead extractions each year should train physicians to perform the surgery.

The Heart Rhythm Society also called for tracking the success and failure rates of removal procedures in a national database to give physicians a clearer picture of best practices for the difficult procedures, the Associated Press said.

Medtronic Inc.’s Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. As we reported in March, Medtronic recently sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

If a lead 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.

Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. According to The New York Times, around 150,000 people are still implanted with a Sprint Fidelis lead.

According to the FDA, the new technology issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a press release. “While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

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.

Medtronic suspended sales of the Sprint Fidelis Leads last October after receiving reports of 5 fatalities linked to lead fractures. The Sprint Fidelis had been fracturing at a rate of 2.3% over a 30-month period, more than twice that of an older Medtronic lead, called the Sprint Quattro.

By the time Medtronic issued the recall, the lead had green implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide. The FDA says most of the patients with the Sprint Fidelis lead still have the device implanted because of the danger associated with removal, and are being monitored by their health-care providers for potential fracture.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S.   In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators.   According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S.  and 2,000 more such removals took place overseas.  The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes.  Yet in spite its claims that it acted properly, Medtronic is now settling thousands of defective Marquis Defibrillator Lawsuits.    The company will pay a total of $114 million, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fee.

Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices.  In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure.  The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient’s life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators.   According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt.   This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal.   At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync.  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.

Lead replacement is also an expensive procedure, and can cost in excess of $12,000.  And even though it made the defective Sprint Fidelis Lead that is now causing so many patients so much anxiety, Medtronic is doing little to absorb the costs of lead replacement.  When it first announced the Sprint Fidelis Lead recall in October, Medtronic said would cover the cost of a new lead, as well as pay $800 in medical costs for patients whose lead had fractured.  But later, the company extended that coverage to patients without fractures, in cases where doctors advise removing the leads because of the patient’s specific medical condition.  Even with Medtronic’s contribution, however, patients who have their Sprint Fidelis leads replaced could still be left with a large medical bill.  So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured.

Patients whose doctors don’t recommend the removal of the Sprint Fidelis Lead have little choice to wait and hope it does not fail.  Their defibrillators will need to be reprogrammed and monitored, to improve the odds of catching any developing fractures early.  But this precaution does not come with a guarantee that all Sprint Fidelis Lead failures will be caught before a patient is injured, and the component could still fracture without warning.

The number of people left to worry that their Sprint Fidelis Lead will one day fracture is staggering.  Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests.   It will be a long time – if ever – before all of these Sprint Fidelis Lead patients can feel secure.

In Canada, 2,416 patients had the Medtronic defibrillators implanted as of February 2005, with 613 of them having been removed or replaced as of June 2007.

In 2005, Medtronic announced that it was recalling two heart defibrillators because they had been linked to at least four deaths and one injury. These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia’s, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock.   Medtronic said that some of the recalled defibrillators failed to charge properly, a defect which can result in the late delivery or no delivery of cardiac shock therapy. Medtronic had actually discovered the problem with its defibrillators in 2003, but did not disclose the problems immediately.

In October, Medtronic agreed to pay $130 million to settle U.S. claims it hid the defects in the defibrillators, $55 million more than it proposed in a July settlement, people familiar with the agreement said at the time. The company agreed to the higher amount after more claims were filed over the heart defibrillators than the parties expected, the people said.

But the October settlement was not the end of Medtronic’s defibrillator woes.   That same month, Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync.  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.

Just last week, lawyers for Medtronic went before the US Supreme Court to ask  that people injured by defective  medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration.

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync.  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.  Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months.  The incident has raised questions about the Food & Drug Administration’s (FDA) regulation of medical devices, and of the Medtronic’s response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic’s suspended distribution of its Sprint Fidelis family of defibrillation leads.  The Senate panel is probing the FDA’s oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments.  The U.S. attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices. The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn’t identified in the SEC filing.  In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic’s relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company’s payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use.   Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products.   Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

The Medtronic Supreme Court case 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.

Medtronic is arguing that because Congress granted the FDA the authority to determine whether products are safe and effective, state judges and juries should not be allowed to second-guess the FDA once a product is approved for use.  Now, the Supreme Court must decide if Congress intended to bar state law claims when it gave the FDA authority to regulate medical devices in 1976. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims, and device manufacturers didn’t argue that they did until recently. Medtronic and other companies are claiming that allowing state personal injury lawsuits against the makers of defective medical devices and drugs would amount to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Consumer and patient advocates are vigorously opposed to Medtronic’s arguments.  They fear that by removing the threat of lawsuits, manufacturers like Medtronic would have no incentive to keep devices and drugs that they know are defective off the market.  And the FDA cannot be trusted to keep consumers safe, because the agency has approved some drugs – like Vioxx- and devices based on sloppy or falsified test data.  Patient advocates insist that often, lawsuits are the only way evidence of such fraud or faulty tests ever come to light.  Finally, consumer advocates fear that the FDA is simply not up to the job of keeping unsafe drugs and medical devices away from the public.  A report issued Friday by three members of the FDA’s own Science Board said that the agency was so poorly organized and short of funds that it could not adequately protect the public. 

Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync.  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.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was introduced in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators.  But within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. A data analysis performed by the Minneapolis Heart found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor.

But lead fractures might be only one of the Sprint Fidelis’ problems.  According to a the website TheStreet.com, a report by a Deutsche Bank analyst regarding the impact of the Sprint Fidelis Lead wire recall on Medtronic’s bottom line said that more bad news could be on the way.  The analyst wrote that there had been reports that the Sprint Fidelis Lead wires had poor sensing capability.  The Deutsche Bank report said that concerns over the Sprint Fidelis Defibrillator Lead wires sensing capabilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”

The Sprint Fidelis Defibrillator Lead recall has hurt Medtronic’s bottom line.  Earlier this week, the company said that revenue in its Cardiac Rhythm Disease Management unit was down by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter. Last month, Medtronic had predicted a $150 million to $250 million loss of second-quarter revenue and inventory write-off costs of $15 million to $20 million.  The Deutsche Bank report also speculated that further problems with the Sprint Fidelis Lead wire could weigh even more heavily on Medtronic’s finances.   The analyst wrote that the Sprint Fidelis problems could result in permanent loss of market share in implantable defibrillators to other company’s such as St. Jude Medical and Boston Scientific.