Medtronic Pacemaker Attorneys

Medtronic has recalled 87,000 of its defibrillators because of a battery depletion problem.

Battery Shorting

On February 11, 2005, Medtronic Inc. issued a statement to physicians advising them that over 80,000 implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are prone to battery depletion and failure. The battery shorting mechanism could cause the battery in these defibrillators to experience a rapid depletion of power resulting in the loss of device function. The particular devices affected were manufactured between April 2001 and December 2003 and include:

• Marquis VR Model 7230
• Marquis DR Model 7274
• Maximo VR Model 7232
• Maximo DR Model 7278
• InSync Marquis Model 7277
• InSync II Marquis Model 7289
• InSync III Marquis Model 7279

In Medronic's February 2005 statement to physicians, Medtronic said the battery shorting problem can cause the batteries in these devices to become rapidly depleted, sometimes within hours or days. After the battery is depleted, the device will no longer function.

Failure to Charge

On April 16, 2004, Medtronic announced that it was recalling two other heart defibrillators because they have been linked to at least four deaths and one injury. Medtronic said that Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 failed to charge properly which can result in the late delivery or non-delivery of cardiac shock therapy. Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are thought to be still in use.

These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmias, 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 with the suspect defibrillators, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or non-delivery of shock therapy. A delay or non-delivery of shock therapy can be life threatening.

The U.S. Food and Drug Administration (FDA) has been apprised of the defibrillator recall and has classified this action as a Class I recall. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

The following models may be defective:

• Medtronic Marquis VR model 7230, batteries manufactured before December 2003.
• Medtronic Marquis DR model 7247, batteries manufactured before December 2003.
• Medtronic Maximo VR model 7232, batteries manufactured before December 2003.
• Medtronic Maximo DR model 7278, batteries manufactured before December 2003.
• Medtronic InSync Marquis model 7277, batteries manufactured before December 2003.
• Medtronic InSync II Marquis model 7289, batteries manufactured before December 2003.
• Medtronic InSync III Marquis model 7279, batteries manufactured before December 2003.
• Medtronic InSync III Protect model 7285, batteries manufactured before December 2003.
• Medtronic Micro Jewell II model 7223Cx.
• Medtronic GEM DR model 7271.
• Medtronic Sigma pacemakers

Advances in science and technology have led to the creation of medical devices that allow patients to live a longer, more comfortable life. Unfortunately, there are flaws in manufacture and operation in some of these devices which lead to injury and death. The Guidant Corporation recently recalled several models of its implanted defibrillators which affects over 50,000 implant victims and St. Jude announced that some of its implantable defibrillator models, or ICDs, have a software problem that could cause the heart-shocking device to malfunction.

Companies that manufacture or sell products must be held accountable for their actions including the sale of defective products. The Law Offices of Nadrich & Cohen is a national products liability law firm with extensive experience fighting large corporations who have unnecessarily caused injuries and deaths to patients and victims. Our team of expert product liability lawyers are investigating Medtronic Pacemakers that have been recalled. We are aggressively representing Medtronic Pacemaker victims.

If you or a loved one have suffered injuries or have legal concerns related to these products, please immediately contact us at (800) 718-4658. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

We work on a contingency basis only. A contingency fee means we do not charge for our services unless we obtain a recovery for our clients. If we do not obtain a recovery, our clients owe us nothing.

Our experienced attorneys have recovered tens of millions of dollars on behalf of our injured clients. Please allow our team of defective product liability lawyers help you for the pain, suffering, and injuries caused by a Medtronic Pacemaker.

"October 15, 2007"

Heart Device Maker Predicts Sales Drop By BARNABY J. FEDER

Medtronic said this morning that it expected revenue to fall by as much as $250 million, or 7 percent, as a result of the problems it disclosed Sunday with a crucial component in the most recent model of its heart defibrillator. Stock in the company, the world's largest maker of the devices, plunged on heavy volume when trading opened this morning. Shortly after 10 a.m. the stock was down $5.73, or more than 9 percent, to $50.60.

Medtronic announced Sunday that it was urging doctors to stop using an electical lead, or wire, known as the Sprint Fidelis, because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths. The wire connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the estimated 235,000 patients with the Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device to misread heart-rhythm data. Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need. In most cases, the defibrillators can be reprogrammed without surgery to minimize the problem.

Although the company says that the Fidelis leads can be replaced, if necessary, with an older version called the Quattro, it said today that it currently does not have enough Quattros on hand to replace all the wires that might prove faulty.

Doctors in many cases could choose to use replacement leads made by other companies. But the biggest long-term financial impact on Medtronic might come not from doctors using other leads but from the possibility that they could switch to complete defibrillator packages from other companies. Medtronic said today that the biggest financial impact would probably be in Japan, because it does not have approval there to sell its Quattro lead as an alternative to Fidelis. Because Japanese doctors customarily do not mix leads and defibrillators from different companies, Medtronic could lose sales of both leads and defibrillators there.

Overall, Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said. Medtronic said it would stop selling the lead and recall all leads not yet implanted. Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly. The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have them. Patients who have recently had defibrillators replaced because their batteries were running down may not have the leads because doctors commonly attach replacement defibrillators to the existing leads when possible. Vice President Dick Cheney uses a Medtronic defibrillator, but it was implanted in 2001, before the Fidelis lead was introduced. The White House declined to comment on Sunday.

Questions about the performance of the Fidelis lead have surfaced before. For example, earlier this year, Dr. Robert G. Hauser of the Minneapolis Heart Institute published an analysis that found, among other things, that a significant number of patients were experiencing "inappropriate" shocks because their defibrillator was firing when not needed. Such jolts can be extremely painful.

Dr. Hauser, who played a central role several years ago in bringing to light malfunctions in defibrillators made by a Medtronic competitor, Guidant, said that he discussed his findings earlier this year with Medtronic officials, who said there was not enough data to come to any conclusions. In March, however, the company issued a letter to doctors sharing those concerns with doctors.

Last month, when 30 months of data showed a continuing fracture problem, Medtronic began talking with its independent medical advisers about what to do next. "The numbers that we saw were not that bad, but they were worrisome, troubling," said Dr. Douglas P. Zipes, a professor at the Indiana University School of Medicine and a member of the advisory board.

Statistically speaking, there is not enough data to be sure that Fidelis is unusually prone to fracture. But with mounting evidence that there was cause for concern, Medtronic said it decided to act now. Five deaths have been linked to the fractures as a possible, though not confirmed, contributor. The numbers suggesting that the problem was significant enough to halt sales of the lead come from two other sources: a clinical trial currently following the progress of 650 patients at 17 hospitals and the mountain of data collected from 25,000 patients in CareLink, Medtronic's system for remotely monitoring implants. Medtronic said that data from fractured leads that have been returned had helped it understand where the malfunctions occur. Federal safety regulators, who participated in the announcement yesterday, endorsed Medtronic's decision to stop selling the lead. "Pulling this device from the market is the right thing to do," said Daniel G. Schultz, director of the Center for Devices and Radiological Health at the Food and Drug Administration.

The recall is the latest in a series of setbacks for Medtronic and its two main rivals in the $6 billion global defibrillator market, St. Jude Medical and Boston Scientific, which now owns Guidant. Sales have slumped in the United States in the last two years because of a string of safety recalls and concern among doctors that it is too difficult to identify which patients would benefit from the devices. They can cost $30,000 or more.

Medtronic, which had $12.3 billion in sales last year, has more than 55 percent of the defibrillator market, and the devices are its biggest product. Medtronic said it would cover the cost of a replacement lead for those that have fractured, plus up to $800 in medical expenses that are not covered by insurance. But the company will not pay for procedures to replace functioning leads that patients want taken out to head off possible problems in the future, a company spokesman, Robert Clark, said.

Mr. Clark said Medtronic would attempt to design a similarly narrow lead to replace the current products. Although Medtronic is recommending that doctors switch back to its older Quattro lead, Medtronic said that none of its pacemakers used the leads. Pacemakers are device that, instead of shocking a heart back into a stable rhythm, are meant to ensure a continuous steady beat. Medtronic developed Fidelis as part of the race among cardiac device companies to develop ever more compact and flexible products that can be implanted more easily and safely.

Whatever happens, Medtronic is hoping to contrast its response with that of Guidant three years ago, when deadly defects were discovered in some of its defibrillators. Guidant, which Boston Scientific acquired in 2006, angered doctors and regulators by failing to quickly disclose the problems. Since then, the Heart Rhythm Society, the professional group for doctors who implant defibrillators, has developed guidelines for handling product safety problems. Dr. Schultz at the F.D.A. said the company's actions were an indicator of how much the industry had learned from the mistakes made in handling the Guidant malfunction. Dr. Hauser, the Guidant whistle-blower, agreed. "I think that in the old days, this lead could have continued on the market for a long time, maybe forever," he said. Barry Meier contributed reporting."