Some women from Oklahoma have sued California-based medical supply company Mentor Corp., claiming the company’s device to treat urinary stress incontinence is defective and caused them serious injuries.

The women filed three lawsuits on Feb. 29 in Payne County District Court, alleging the ObTape Vaginal Sling caused chronic pain, infections, and erosion of vaginal tissues, among other problems. The Mentor Corp., based in Santa Barbara, has not commented on the suits.

“It felt like someone had pulled my legs apart and just stretched them,” one claimant said at a news conference. “I was finally relieved to know what caused it; you keep wondering what was wrong with you.”

And for some women, simply realizing they had the device was a surprise.

“We have found many women do not know they have this product inside their bodies,” one lawyer said.

Source: The Associated Press, “Oklahoma women file lawsuits against medical device maker Mentor,” March 18, 2008. (http://www.cnbc.com/id/23695109/for/cnbc/print/1/displaymode/1098/)

There may be a higher death rate after five years among patients treated for abdominal aortic aneurysms with a Medtronic Inc. device than among those treated through conventional surgical means, according the U.S. Food and Drug Administration.

A public-health notification posted on the FDA’s Web site said the agency was looking at Medtronic’s AneuRx stent-graft system because it is the only currently marketed device that has a significant number of patients who have been examined for at least five years after receiving a device.

The device is generally inserted through an artery in the leg in order to prevent bulging blood vessels in the abdomen from rupturing, which can be fatal.

Source: Jennifer Corbett-Dooren, The Wall Street Journal, “FDA Notes Medtronic Device Deaths,” March 19, 2008.

The “Sunshine Act,” introduced in Congress earlier this year, states that medical device manufacturers must publicly disclose particular monetary transactions involving physicians who assisted with product training, development, and research.

The purpose of the bill is to help prevent inappropriate relationships that may form between physicians and medical device makers.

Medtronic, Inc., a manufacturer of medical devices such as defibrillators and insulin pumps, disputes the bill for not including all companies that make devices. In its current form, the bill does not include companies with annual revenues of less than $100 million. The bill also does not include physician-owned companies. Medtronic alleges that 75 percent of medical device manufacturers fall into one of those two categories and should be included in the bill.

Source: Toni Clarke, “Medtronic says ‘Sunshine Act’ should go further.” Reuters.com, http://www.reuters.com/article/rbssHealthcareNews/idUSN2634844420080226 February 27, 2008.

Donald Jackson received a defibrillator implantation in 2006 that included a lead wire manufactured by Medtronic, Inc. The lead, known as the Sprint Fidelis, was voluntarily recalled by Medtronic in late 2007 amid reports of unnecessary and repeated shocks to patients as a result of fractures to these leads.

Jackson has sued Medtronic, claiming he suffered excruciating pain when he was subjected to unnecessary shocks, and now requires psychiatric treatment to deal with the ongoing stress of his predicament.

Defibrillators are intended to administer electric shocks to a patient’s heart in order to regulate an abnormal heartbeat. Lead wires implanted directly in the heart muscle connect to the defibrillator unit, sending information to the unit about the patient’s heart rhythm. A break or “fracture” in the wire results in mixed electrical signals being sent to the defibrillator that may cause unnecessary painful shocks to the patient. Sprint Fidelis leads were recalled after Medtronic acknowledged that the leads have a higher failure rate than that of their predecessor product, the Sprint Quattro lead.

In the current lawsuit – one of many such suits filed across the country – Jackson claims his Sprint Fidelis lead is defective and has caused much “physical, emotional, and psychological suffering and extreme anxiety.” Jackson has been prescribed medications to deal with his anxiety, but claims he still has an “imminent apprehension of death.” The suit also alleges that “as a result of problems with the lead, [Jackson] has an increased risk of death or major heart problems.”

Jackson seeks punitive damages from Medtronic on the basis that the company acted in an “intentional, reckless, and grossly negligent” manner in the manufacture and marketing of the Sprint Fidelis lead. Suit was filed on January 18, 2008, in U.S. District Court.

Source: “Lead Shocks Send Patient to Psychiatrist, Courtroom.” Fdanews.com, February 4, 2008.

Medtronic Inc. announced today a $114.1 million agreement to settle 2,682 lawsuits related to its implantable Marquis cardiac defibrillators. Still, the Minneapolis-based company said it does not admit liability or the validity of the plaintiffs’ allegations in litigation against the defibrillators.

“We are pleased to settle these cases and put the matter behind us,” said Pat Mackin, who is the senior vice president and president of Medtronic Cardiac Rhythm Disease Management. “We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic.”

The announcement comes nearly three years after Medtronic announced a potential battery shorting problem in the Marquis-brand defibrillators in February of 2005. Some 13,000 devices were surgically removed and replaced worldwide.

According to the suits against Medtronic, the company knew for years that there was a potential for defects but sold the devices nonetheless, failing to advise patients that there were safer devices available.

Source: CNNMoney.com, “UPDATE: Medtronic Settles ICD Lawsuits for $114.1 Million,” December 21, 2007.

Bayer AG announced a seven-country recall of Contour TS diabetes test strips due to a manufacturing problem that could lead to blood sugar readings higher than actual levels of glucose. According to a release from the U.S. Food and Drug Administration, glucose test results returned by the recalled strips generally show up five to 17 percent higher than the user’s actual glucose levels.

The recalled Contour TS test strips have lot numbers beginning with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). The recalled lots have the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence.

Consumers may contact Bayer at 1-800-348-8100 to return recalled test strips for a replacement.

Source: U.S. Food and Drug Administration, MedWatch, “Test Strip Recall for CONTOUR TS,” December 21, 2007.

Cardinal Health and the U.S. Food and Drug Administration updated the public on a worldwide recall of Alaris Pump modules today, informing consumers that the medicine-infusion systems may overinfuse, which could prompt serious, life-threatening side effects. The Alaris Pump recall involves model number 8100, which was formerly known as the Medley Pump.

According to the FDA’s statement on December 20, 2007, the recalled Cardinal Health Alaris Pumps may contain occluder springs that are bent, broken, nested, or missing. This could cause the pump to malfunction, and perhaps lead to overinfusion of medicine. But according to the FDA, overinfusion can be difficult to detect because there is no warning or notification from the pump itself that it is injecting too much medicine.

Cardinal Health has received one injury report and two reports of patient deaths associated with use of the recalled Alaris Pumps, however the company maintains that neither they nor the respective hospitals could confirm that use of the device definitively caused the deaths.

The FDA urges consumers to contact Cardinal Health with any inquiries related to the recall. The company’s phone number is 1-800-625-6627, and its Web site is www.cardinalhealth.com. According to Cardinal Health, it will have representatives answering phones around the clock, seven days a week.

Source: U.S. Food and Drug Administration, “Cardinal Health Statement on Alaris Pump Module Worldwide Voluntary Recall,” December 20, 2007.

A consumer advocacy group wants the United States Food and Drug Administration (FDA) to warn consumers about infection risks and the limited lifetime of implanted medical devices in product ads.

Consumers Union is targeting advertisements for implantable devices, such as knee implants, and cosmetic implants in its petition to the FDA.

“We are only asking that consumers be given clear warnings about the dangers of infection during and following surgery,” the petition reads. “And information about how the devices are likely to last, and that consumers be advised to seek out facilities with the strongest anti-infection programs and devices with long term data about failure rates.”

The petition cites a June 2006 publication of Consumer Reports, in which a study found five percent of respondents reported having an infection after implant surgeries. Some of those infections were of Methicillin-resistant staphylococcus aureus (MRSA), which can be lethal. Other postoperative infections cited were deep vein thrombosis (DVT), pulmonary embolism, and decubitus ulcer.

Consumers Union is an independent and non-profit organization that publishes Consumer Reports.

Source: Consumers Union, Citizen Petition to the U.S. Food and Drug Administration, December 11, 2007; “Drug-resistant bug raises new concerns,” Consumer Reports, June 2007.

On December 11, 2007, a 48-year-old man underwent surgery to have his Medtronic defibrillator and lead wires replaced after the Sprint Fidelis lead was linked to five deaths.

A defibrillator is meant to deliver electric shocks to the heart to restore normal rhythms if a patient’s heart starts beating erratically. During implantation of the device, lead wires are also implanted that connect the defibrillator to the patient’s heart. One of the most widely-used leads, the Sprint Fidelis lead, was recently pulled from the market when its’ manufacturer, Medtronic, announced that the Sprint Fidelis lead carries a higher risk of failure (fracture) within the first 30 months of use than its predecessor product, the Sprint Quattro lead.

If a lead fractures it could prevent the defibrillator from firing when needed. Fractured leads may also suffer from disruptions in their sensing mechanism, causing them to deliver unnecessary and perhaps repeated shocks.

In some instances a defibrillator is implanted to serve a dual purpose, also acting as a pacemaker for the patient’s heart. In these situations the failure of a lead like the Sprint Fidelis lead could have devastating consequences for the patient.

The December 11 surgery came two months after Medtronic warned doctors and patients that the lead might break. The warning has left many patients wondering if they should have the faulty lead removed, or leave it in place and hope it does not fracture.

The risks involved during removal surgery, besides infection, include perforation of the heart and veins in the chest. Some patients also face a risk of damage to the heart valve through which the Sprint Fidelis lead lead was threaded.

Each lead replacement procedure can cost $12,500 or more. Medtronic has offered only to contribute a replacement lead and $800 towards the procedure, and insurers are debating whether to cover the surgery on a case-by-case basis.

While most Sprint Fidelis lead users will not need the operation, all have been advised to check with their doctors. The number of patients potentially affected by the faulty leads – nearly a quarter of a million – makes this the most widespread heart device problem in the country’s history. It is the latest example of errors in a medical device industry that has been plagued by design defects, lax quality control, and product recalls such as the Guidant defibrillators in 2005 that were linked to seven deaths.

“It seems like a good time to figure out where we are in regulating leads and what we can do better,” said Daniel G. Schultz, director of the FDA’s center for devices and radiological health.

A Detroit woman said her husband had his Sprint Fidelis lead reprogrammed to safer settings by a Medtronic representative, but still planned to seek a second opinion at the Cleveland Clinic.

“Maybe nothing will happen,” she said, “but if it does I want him to be a patient of someone known to be a high-volume expert.”

In October 2007, Medtronic said the Sprint Fidelis lead fractures at a higher rate than the Sprint Quattro, which Fidelis has been displacing since 2004. Data from Medtronic suggests 2.3 percent of Fidelis implants fracture within 30 months. While experts believe data from the lead’s manufacturer is likely conservative, even at these estimates some 4000-5000 patients in the United States are at risk of fracture.

Dr. Raymond H.M. Schaerf, a surgeon at Providence St. Joseph Medical Hospital in California, has removed six Fidelis leads from patients since the October 2007 warning. Dr. Schaerf also said he has turned 10 patients away, though, indicating replacement procedures are too risky in those particular patients’ situations.

Robert G. Hauser, a Minneapolis cardiologist, said he is organizing a registry to track performance of the Sprint Fidelis lead and other leads, in order to get a better grasp on the specific risks involved.

Source: Barnaby J. Feder, “Patients wonder whether to replace a wire that might fail,” New York Times, December 13, 2007.

Once the FDA approves a drug or medical device, state judges and juries will not be permitted to hear cases alleging defects in these products, nor will they have authority to hold manufacturers accountable for the injuries caused by their defective (but FDA-approved) products.

At least that’s what pharmaceutical manufacturers hope will be the case when the United States Supreme Court issues a decision in Riegel vs. Medtronic.

Charles Riegel sued Medtronic Inc. over an allegedly faulty catheter manufactured by the company. While the lawsuit was filed in federal court, the basis for Riegel’s claims is found in state law. The suit was thrown out, as the lower court ruled that if Riegel got to trial and won, it would be the equivalent of the states imposing additional “requirements” on the manufacturer beyond those established by the FDA during its pre-market approval process for medical devices such as the Medtronic product in question.

The theory behind the court’s decision is called “preemption” – namely, while individual states have authority to govern themselves, they may not impose additional (or more stringent) guidelines in an area already legislated by the federal government.

Riegel appealed the decision and oral arguments were heard by the Supreme Court during the first week of December 2007. The court is now left to decide whether FDA pre-market approval of a medical device means parties injured by that device may not seek remedies under state law.

State liability poses a “Catch-22 [for pharmaceutical companies] between complying with FDA regulations on the one hand and still being subject to state liability on the other,” said Rob Clark, a government affairs director for Medtronic.

Consumer-advocate groups are outraged, arguing that state courts offer the chance for those injured by faulty medical drugs and devices to receive compensation for the harm suffered. They argue the FDA sometimes makes decisions based on inaccurate or insufficient information, which makes the state courts a second (and often last) chance venue for consumer protection.

Either way the Court rules, the decision will likely have a dramatic and far-reaching impact on current and future product liability claims in the United States.

Source: Molly Selvin, “High court may bar claims for FDA-approved drugs,” Los Angeles Times, December 4, 2007.

On November 28, 2007, a second lawsuit was filed against the manufacturer of the recalled Spring Fidelis lead, Medtronic Inc.

On August 12, 2007, in Bowling Green, Kentucky, Kim Orange’s defibrillator failed and caused her to receive three electrical shocks. Orange was transported from Bowling Green to Vanderbilt University Medical Center in Nashville, Tennessee, by ambulance. She suffered two more shocks the same day.

Orange alleges the shocks from a defective Spring Fidelis lead connecting her defibrillator to her heart forced her to undergo complicated surgery to remove the faulty device and implant a new lead system. Orange contends surgery further damaged her heart.

Approximately 235,000 people are potentially affected by Medtronic’s recall of the Spring Fidelis lead wires on October 15, 2007. The recall came following five reports of death in which the Spring Fidelis lead fracture was a contributing factor. Orange’s complaint claims a design defect in the small diameter of coil and conductors used in the leads attributed to Orange’s lead failures. The combination of design defect and stress damage occurring during and after the implantation can cause the conductors to become overstressed, thus creating a fracture in the wires.

“You fear that you have a ticking time bomb inside your body that could unexpectedly explode or be triggered by a quick movement or vibration,” Ms. Orange said. “Exertion such as bending over to make a bed, mowing the lawn and other everyday tasks have become frightening experiences.”

Orange’s lawsuit was filed in Minnesota, where Medtronic Inc is based. The lawsuit seeks damages for physical pain, medical expenses, and compensation for Orange’s future medical care and expenses.

Source: “Kentucky Resident Files Lawsuit against Medtronic for Faulty Defibrillator Lead Wire That Caused Devastating Electrical Shocks,” Newswire, November 28, 2007.

November 28, 2007 – Approximately 235,000 people are potentially affected by Medtronic’s recall of the Sprint Fidelis lead wires on October 15, 2007. Medtronic recalled the lead wires after receiving reports of five deaths that linked a Sprint Fidelis lead fracture as a contributing factor.

A Bismarck, North Dakota woman, Winnifred Leverson, filed a lawsuit on Monday against Medtronic. Although Leverson’s defibrillator is working properly, her lawsuit alleges that she suffered emotional distress and negligence. The lawsuit seeks restitution and medical monitoring.

“She would like not to have a potentially defective lead in her,” Leverson’s attorney said. “Living with one of these defibrillators is a bit like living with a ticking time bomb in your chest.”

The amount of personal injury damages Leverson demands is unknown.

The Sprint Fidelis was introduced in 2004 to replace a previous model, Sprint Quattro, in Medtronic’s line of defibrillator lead wires. The Sprint Fidelis lead wire connects an implantable defibrillator to the heart and, if working properly, provides an electrical shock if it senses an out of sync heart rhythm.

Medtronic’s Sprint Fidelis lead wires were shown to have a fracturing problem. Medtronic and the U.S. Food and Drug Administration (FDA) approximate the risk of breakage to be less than one percent. However, if the Sprint Fidelis lead wires do fail, devastating and sometimes fatal adverse events could follow. The fracture defect could cause the defibrillators to deliver a massive and painful electrical shock. The fracture defect could also cause the device to fail to administer lifesaving shocks to people at risk of cardiac arrest.

In an article written by doctors at one of the premier heart institutes in the world, The Minneapolis Heart Institute, researchers found the Sprint Fidelis Lead had a higher chance of fracturing compared to Medtronic’s older model, the Sprint Quattro. According to Medtronic’s own data, approximately 2.3 percent of heart patients, or 4,000 to 5,000 people, will experience a Sprint Fidelis Lead fracture within 30 months of lead wires implantation.

In addition to the risk of lead wire fractures, recent articles have reported that the recalled Sprint Fidelis lead may also provide poor sensing capabilities, adding further concern that inappropriate shocks may be caused. This discovery of yet another potential defect in the already troubled Sprint Fidelis Lead may soon be published in medical journals.

Sources: Elizabeth Trotta, “More Faults in Halted Medtronic Device?” November 26, 2007; “Bismarck woman sues Medtronic over recalled defibrillator wires,” Charlotte Examiner, November 27, 2007; “Woman Sues Over Recalled Heart Devices” kfyrtv.com, November 27, 2007; RG Hauser, et. al., “Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead“, PubMed, July 2007;“Medtronic Sprint Fidelis Defibrillator Lead Could Have Sensing Capability Problems,” News Inferno, November 27, 2007.

On October 19, 2007, the United States Food and Drug Administration (FDA) issued a Class 1 recall for Thoratec Corporation’s Implantable Ventricular Assist Devices (IVAD) due to a possible product defect.

A Class 1 medical device recall is the most serious type of recall, involving situations in which there is a reasonable probability that the use of the product may cause serious personal injury or death.

The recalled IVADs are air-driven pumps designed to provide sufficient blood flow to damaged or diseased hearts. The IVADs may be used internally or externally to help a cardiac patient survive until a heart transplant can be performed. Only external IVADs are affected by the recall.

When placed in an external position, air leaks may develop. These air leaks are the result of sharp bending of the driveline at the connection to the pump, and could lead to reduced blood flow to and from the heart.

Recalled external Thoratec Corporation IVADs were distributed to eighty-seven hospitals in the United States and other countries from October 1, 2004 through October 22, 2007. IVADs affected by the recall have a catalog number 10012-2555-001 and serial numbers 488 or higher located on the label of the sterile package and on the driveline’s “Y-connector.”

An Urgent Medical Device Correction notice and new instructions regarding placement and care of the IVAD driveline were sent to all customers. Doctors are instructed to contact their patients if any Thoratec IVAD is placed in the external position. Patients with an external Thoratec IVAD should consult their doctor for further information.

Source: U.S. Food and Drug Administration, “Class 1 Recall: Thoratec Corporation Implantable Ventricular Assist Devices (IVAD)”, October 19, 2007.

On November 12, 2007, the Wall Street Journal reported concerns over St. Jude Medical Inc.’s Riata line of defibrillator leads. The Riata line of defibrillator leads are wires used to connect an implantable defibrillator to cardiac patients’ hearts. The wires are under scrutiny for possible flaws, as in rare instances the leads may lead to punctures.

There have been four recent cases involving patients in Nebraska, New York City, and the Czech Republic. These cases have been reported to St. Jude and the U.S. Food and Drug Administration (FDA), and will be printed in the online medical journal Pace.

Defibrillator leads are affixed to the wall of the heart and are designed to sense a heart’s rhythm. When an unstable rhythm is detected, the implanted defibrillator is supposed to dispatch an electrical shock.

In four reported cases, St. Jude Medical’s Riata defibrillator leads became detached from the heart. Detached defibrillator leads could cause very serious injuries. Riata leads might poke holes through the heart. In one reported case, Riata leads nearly poked through a patient’s skin. A punctured heart could bleed into the pericardial sac, causing a lethal condition in which pressure builds around the heart, rendering it unable to beat effectively.

In addition, if a Riata lead is detached from the heart it may not sense aberrant heart rhythms and a patient might suffer serious consequences, including death, from an underlying medical condition.

“There is a legitimate concern that the problem may be more than physician misadventure and that there may be an inherent design flaw, at least in some models of the Riata leads,” wrote Dr. Steven C. Vlay, a cardiologist and heart-rhythm specialist at Stony Brook University in Stony Brook, NY, in a Pace editorial.

The president of St. Jude’s cardiac-rhythm management division, Eric Fain, said perforation rates with the 121,000 Riata leads implanted so far are at or lower than those reported for other defibrillator leads. In a registry created by St. Jude Medical to track patients implanted with Riata leads, a perforation rate of 0.33% has been seen in 1,207 patients implanted with all Riata leads.

However, reports published earlier this year by the journal Heart Rhythm showed higher perforation rates. In April, Massachusetts General Hospital reported a 3.8% rate of perforation in certain models of Riata leads. The New York Hospital Queens reported that they saw five perforations out of the 59 Riata leads implanted in their hospital – a failure rate of 8.5%.

The number of perforations caused by Riata leads could be higher than reported since these experiences are not always reported by doctors.

The Riata lead is the second defibrillator lead under scrutiny this year. In October 2007, Medtronic’s Sprint Fidelis defibrillator lead was removed from the market after the company reported it may fracture at a higher rate than another Medtronic lead, the Sprint Quattro.

Source: Thomas M. Burton and Anna Wilde Matthews, “St. Jude Defibrillator Wire Gets Scrutiny,” Wall Street Journal, November 12, 2007.

On October 30, 2007, Welch Allyn issued a Class I recall of nearly 2,000 AED 10™ Automatic External Defibrillators because they may experience failure or an unacceptable delay, resulting in the device not delivering appropriate therapy. If this happens, this could cause a failure to resuscitate a patient.

The recalled defibrillators are used by emergency and medical personnel to treat adults who are having a heart attack. They work by analyzing a patient’s heart rhythm and automatically delivering an electrical shock to the heart in order to restore normal heart rhythm. A Class I recall is the most serious type of medical device recall, and involves situations where there is a reasonable probability the recalled device will cause serious personal injury or death.

Welch Allyn has reports of 49 failures and three customer complaints about a delay in the devices. The failures were caused by defective capacitors, and defibrillator malfunctions include:

• a flashing status indicator;
• excessive battery drain, which causes shortened battery life;
• the device continuously resetting itself, making it non-operational; and
• the device not delivering shock when it is expected to do so.

The AED 10™ Automatic External Defibrillators involved in the recall were manufactured between March 29, 2007 and August 9, 2007. They have part numbers 970302E, 970308E, 970310E, and 970311E.

Owners of recalled AED 10™ Automatic External Defibrillators should contact Welch Allyn at 1-800-462-0777 for information about exchanging the device.

Sources: “Welch Allyn Issues Voluntary Worldwide Recall of Select AED10 Automatic External Defibrillators,” Welch Allyn Press Release, October 30, 2007 (http://www.welchallyn.com/pressroom/releases/2007/2007-10-30%20-%20AED%2010%20Recall.htm); “Class 1 Recall: Welch Allyn AED 10™ Automatic External Defibrillators,” US Food and Drug Administration Recall Release, October 26, 2007.

In January 2007, two patients went to the Minneapolis Heart Institute because their heart defibrillators jolted them with painful, unwarranted electric shocks – one woman was zapped 14 times in one hour. After doctors began checking medical records, they found four similar cases had occurred in the previous seven months. All six cases involved a break, or fracture, in Medtronic Inc.’s Sprint Fidelis 6949 – a tiny wire, or lead, that connects a patient’s defibrillator to her heart.

The Minneapolis doctors who treated these patients took their findings to Dr. Robert G. Hauser, a senior consulting cardiologist at the Heart Institute. After conducting his own research, Dr. Hauser found similar reports of the Sprint Fidelis fracturing. The Heart Institute then decided to stop implanting the Fidelis leads and substituted an older Medtronic lead, the Sprint Quattro, because it seemed safer.

Approved by the Food and Drug Administration (FDA) in 2004, the Sprint Fidelis quickly became the world’s most widely used defibrillator lead. While the FDA uses its discretion when determining whether a manufacturer should perform a safety study after a device has been approved, the agency did not require a study of Sprint Fidelis. The agency said “no issues were raised in premarket review that suggested the need for postmarket study.” The FDA did not require premarketing testing in human patients for Fidelis because it was similar to an earlier design.

In February 2007, Dr. Hauser contacted Medtronic to notify the company of the product’s “serious problem,” but a Medtronic vice president, Warren Watson, disagreed. At a meeting, Watson said he felt there wasn’t enough evidence that proved the Fidelis lead performed worse than others, and some Medtronic officials even suggested the lead fractures resulted from doctors’ mishandling the devices.

At the same meeting, Medtronic officials provided data which showed that from late 2004, when the device was approved by the Food and Drug Administration (FDA), through February 2007, there had been 226 Fidelis fractures; a 15 percent failure rate. This compared with 64 fractures in Medtronic’s other defibrillator lead, or a failure rate of 0.05 percent.

On March 21, 2007, Medtronic sent a letter to healthcare professionals saying, “Medtronic has received reports from a limited number of implanting physicians indicating they have experienced higher than expected” fracture rates. The letter also advised doctors how to properly handle the device to avoid problems.

In the meantime, Dr. Hauser published findings about the Sprint Fidelis lead fractures in the April 2007 issue of the journal Heart Rhythm. In the manuscript, Dr. Hauser wrote “the Sprint Fidelis high-voltage lead appears to be prone to early failure.” The publication caught the attention of the FDA, but the agency said it lacked details about specific incidents and couldn’t be sure the incidents were all tied to a specific pattern of failure.

By Spring of 2007, doctors who began seeing patients with lead fractures stopped using the Sprint Fidelis in May 2007 after two patients suffered multiple shocks.

“Even though there was no statistical trend yet, I was concerned enough that it might be,” he said.

On July 19, 2007, Medtronic officials again met with Dr. Hauser and other physicians at the Heart Institute, where Dr. Hauser urged the company to stop selling the leads. Reggie Groves, Medtronic’s vice president for quality and regulatory issues, used a slideshow to illustrate that the incidence of fractures still wasn’t statistically significant. Ms. Groves also said the company had identified a problem, but was not going to pull the leads off the market.

Medtronic later said it was aware of five deaths potentially linked to Fidelis lead failures between August of 2006 and September of 2007. Analysts for Medtronic have since estimated that the Fidelis’ overall failure rate is 2.3 percent, more than twice the 0.9 percent rate for its Quattro model.

After consulting an outside advisory committee, Medtronic withdrew all Sprint Fidelis leads from the world-wide market on October 15, 2007.

By the beginning of 2007, 90 percent of all newly implanted Medtronic defibrillators used Fidelis leads. About 268,000 of the devices have been implanted worldwide, and approximately 235,000 remain in patients’ chests today.

Sources: Thomas M. Burton and Anna Wilde Mathews, “Medtronic recall exposes gaps in medical safety,” Wall Street Journal, October 30, 2007; Steve Stiles, “Wall Street Journal chronicles events leading up to Medtronic defibrillator lead recall,” TheHeart.org, October 30, 2007.

A major clinical investigation is set to start this month after a study in Michigan released earlier this year revealed iPods may cause interference with pacemakers up to 50 percent of the time. The study of 100 elderly patients found that an iPod held within two inches of a patient’s chest for five to ten seconds caused pacemaker interference in half of the patients.

Results from the study showed that the players caused:

• over-sensing, where the pacemaker misread the heart’s functioning, in 20 percent of the patients tested;
• interference, in 29 percent of patients tested; and
• pacemaker inhibition, where the pacemaker stops functioning properly for a period of time, in 1.2 percent of patients tested.

Interference was detected when the iPod was held as far as eighteen inches from the chest.

In the upcoming study, four different brands of MP3 players will be tested at three distances. The trial is expected to be completed around September 2008.

Warning of iPods’ interference with heart pacemakers appears on page seven of the iPod touch Product Info Guide, also available online. Apple’s iPod touch manual advises pacemaker wearers, “To avoid potential interference with pacemakers, persons with pacemakers:

• Should always keep iPod touch more than six inches from their pacemaker when the device is turned on;
• Should not carry iPod touch in a breast pocket;” and
• “If you have any reason to suspect that interference is taking place, turn iPod touch off immediately.”

Source: Roger Dobson, “iPods can cause heart pacemakers to malfunction,” The Independent, October 29, 2007;“iPod and Other MP3 Players on ICDS and Pacemakers in Children,” ClincialTrial.gov, October 10, 2007; iPod Touch Important Product Information Guide, Apple.com, 2007.