It seems there is some controversy brewing about the true failure rate for Medtronic Inc.’s recalled Sprint Fidelis defibrillator lead. According to The Wall Street Journal, Medtronic says its own research shows the Sprint Fidelis leads survive for three years at least 95.4% of the time, for a failure rate of 4.6%. But data from some leading hospitals indicates the true rate could be much higher.

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. (more…)

Medtronic Inc. has informed doctors and patients that wiring issues on its  Kappa and Sigma implantable defibrillators could cause the devices to fail. Medtronic’s letter said the issues, which could cause wires that connect the electronic circuit to other pacemaker components to separate,  could affect a total of  37,000  Kappa and Sigma pacemakers.  The company has posted a tool on its website for checking pacemaker serial numbers to determine whether a particular device could potentially have issues.

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. (more…)

Citing  the 2007 Medtronic Sprint Fidelis lead recall, a group of heart doctors has called for changes in the way such devices are approved and monitored.  At a meeting this week in Boston, the Heart Rhythm Society also said more surgeons must be trained to remove the delicate wires that connect an implantable defibrillator to the heart.

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. (more…)

Medtronic has introduced a software update for its implantable defibrillators that will detect lead fractures, which could help the thousands of people implanted with the recalled Sprint Fidelis defibrillator lead. The Food & Drug Administration (FDA) announced the approval of the update,  called the Lead Integrity Alert, yesterday, and said in a press release that it would be of particular help to patients still implanted with a recalled Sprint Fidelis defibrillator lead wire.

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. (more…)

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices.   The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators.  Despite the huge settlement agreement, Medtronic  said it does not admit liability in the litigation.

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.

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Many patients implanted with defective Medtronic Sprint Fidelis Defibrillator Leads have found themselves in a medical limbo.  If they are fortunate enough not to have already experienced a lead fracture, they must decide between two difficult choices – leave the Sprint Fidelis lead alone and hope it won’t fracture; or undergo a difficult and dangerous surgery to have the faulty lead replaced.  Both options are bad ones – a fact that has left many Sprint Fidelis Lead patients anxious and confused.

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.

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Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators.  Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages.

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.

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Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations.   A Senate panel wants information about Medtronic’s October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians.

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.

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Medtronic, Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead and several other defective medical devices, will try to convince the US Supreme Court that people injured by dangerous medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration (FDA).  If Medtronic is successful, the thousands of people injured by the company’s defective devices, as well as those hurt by faulty drugs and devices made by other manufacturers, would not be able to receive compensation for their injuries in state courts.

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Medtronic Sprint Fidelis Defibrillator Lead wires could have even more problems than once thought.  While the Sprint Fidelis Leads where recalled by Medtronic in October because of a higher-than-normal fracture rate, there is now concern that the leads could also have poor sensing capabilities.  This defect could cause a Medtronic defibrillator to deliver inappropriate shocks to the heart.

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.

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