Medtronic Inc.’s stated failure rate for the recalled Sprint Fidelis defibrillator lead has been disputed by some leading hospitals. According to a report in The Wall Street Journal, those hospitals – including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa – say the real fracture rate for the Sprint Fidelis is as much as two times greater that what Medtronic has publicly disclosed.

A lead is a wire that connects an implantable defibrillator to the heart. 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. More Sprint Fidelis Fracture Rates May be Higher than Medtronic Admits

We have long been writing about the dangerous, sometimes deadly, issue regarding defective cardiac device leads. Now, a report out by UBS Investment Research announced that, “lead failures could accelerate over time,” said Med City News.

Lead wires are placed into a major vein and attached to interior heart muscle for the purpose of monitoring heart rhythm and transmitting electric shocks should an irregularity occur. If a lead breaks, the implantable cardiac defibrillator (ICD) can emit a massive and painful shock. And, in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart. More Sprint Fidelis Problems Weigh On Medtronic

Last year we wrote that a prominent physician from the Minneapolis Heart Institute Foundation had expressed concern about test guidelines for a next-generation heart defibrillator under development at the time by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc. Now, Bloomberg News is reporting that Boston Scientific has agreed to pay nearly $300 million to settle an investigation conducted by the U.S. Justice Department on the medical device maker’s Guidant unit and how it handled cardiac devices and manipulation of third-quarter financial results.

Boston Scientific is planning on paying $296 million—approximately one-fifth of its “cash on hand”—and Guidant is planning on pleading to two criminal misdemeanors, said Bloomberg News. The misdemeanors involve not appropriately advising the U.S. Food and Drug Administration (FDA) regarding issues concerning some of its implantable cardioverter defibrillators (ICDs), according to Bloomberg News. Apparently, the investigation involved some advisories that Guidant distributed on its product prior to being acquired by Boston Scientific, said Bloomberg News. The acquisition took place in April 2006. More Boston Scientific Settles Probe Over Defibrillators

Three more lawsuits have been filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted with defective defibrillators made by the device maker, according to the Madison Record.

The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. “Electrodes that sense the heart’s rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous ‘overdrive pace,’ a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected,” the suit states, quoted the Madison Record. More More Claims Filed over Medtronic Sprint Fidelis Leads

Defibrillator lead wires, such a those involved in the 2007 Medtronic Sprint Fidelis lead recall, need better surveillance to detect defects, a group of heart doctors has said. The Heart Rhythm Society also called on hospitals to train doctors in the delicate procedure of removing such wires from patients.

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A lead is a wire that connects an implantable defibrillator to the heart. 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.

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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.

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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.

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.

The Heart Rhythm Society, meeting in Boston this week, pointed to the Sprint Fidelis recall in its call for a surveillance system to track lead performance in order to spot defective devices earlier. According to Reuters.com, the group’s new policy guidelines cover pre-market evaluation and post-market monitoring of the devices, the threshold for action and communication after abnormal lead performance is identified.

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.

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Finally, the Associated Press said the group called on the Food & Drug Administration

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(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.

The procedure to remove one of Medtronic Inc.’s defective Sprint Fidelis defibrillator leads is dangerous and complicated. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

A lead is a wire that connects an implantable defibrillator to the heart. 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. More Medtronic Sprint Fidelis Leads: Doctors, Patients Face Tough Choices

Medtronic’s Sprint Fidelis defibrillator leads have been implicated in at least 13 deaths and could be linked to scores of others. That’s up from the five fatalities Medtronic reported when the Sprint Fidelis leads were first removed from the market in 2007.

A lead is a wire that connects an implantable defibrillator to the heart. 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. More Medtronic Letter Links Sprint Fidelis Leads to 13 Deaths, Possibly More

A new study has found that Medtronic’s Sprint Fidelis defibrillator leads are still putting patients at risk.  The Sprint Fidelis leads were removed from the market in October 2007 because of their higher-than-normal fracture rate.

A lead is a wire that connects an implantable defibrillator to the heart.  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. More Medtronic Sprint Fidelis Risk Grows Over Time

Cardiac stents have been the subject of much controversy in recent months and, now, two emerging studies have found that patients do not fare better over medications and other treatments than with stents following heart attacks.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following such procedures. More Late Treatment with Stents Questioned

A judge who recently dismissed hundreds of Medtronic Sprint Fidelis defibrillator lead injury lawsuits apparently has a personal connection to the device maker.  According to The Wall Street Journal, the son of Judge Richard H. Kyle of the federal district court in Minneapolis is employed by a law firm that has had Medtronic as a client for quite a while.

Medtronic suspended sales of its 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 were told to leave the defective components in place unless they fracture. More Judge Who Dismissed Sprint Fidelis Lawsuits Linked to Medtronic Law Firm