By BARNABY J. FEDERPublished: October 15, 2007
The nation’s largest maker of implanted heart devices, Medtronic, saidyesterday that it was urging doctors to stop using a crucial componentin its most recent defibrillator models because it was prone to a defectthat has caused malfunctions in hundreds of patients and may havecontributed to five deaths.
The faulty component is an electrical“lead,” or a wire that connects the heartto a defibrillator, a device that shocks faltering hearts backinto normal rhythm. The company is urging all of theroughly 235,000 patients with the lead, known as theSprint Fidelis, to see their doctors to make sure it has notdeveloped a fracture that can make the device misreadheart-rhythm data.
Such a malfunction can cause the device to either deliveran unnecessary electrical jolt or fail to provide a life-savingone to a patient in need. In most cases, the defibrillatorscan be reprogrammed without surgery to minimize theproblem.
Medtronic estimated that about 2.3 percent of patientswith the Fidelis lead, or 4,000 to 5,000 people, wouldexperience a lead fracture within 30 months ofimplantation. Those patients will require a delicate surgicalprocedure 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 farmore dangerous than replacing the device itself. As a result, doctors said that patientswere better off leaving the lead in place except in those instances where it has stoppedfunctioning properly.
The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patientswho received Medtronic defibrillators since then have them. Patients who have recentlyhad defibrillators replaced because their batteries were running down may not have theleads because doctors commonly attach replacement defibrillators to the existing leadswhen 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 last night.
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 last night.
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 ananalysis that found, among other things, that a significant number of patients wereexperiencing “inappropriate” shocks because their defibrillator was firing when notneeded. Such jolts can be extremely painful.
Dr. Hauser, who played a central role several years ago in bringing to light malfunctions indefibrillators made by Guidant, said that he discussed his findings earlier this year withMedtronic officials, who said there was not enough data to come to any conclusions. InMarch, however, the company issued a letter to doctors sharing those concerns withdoctors.
Dr. Hauser, who played a central role several years ago in bringing to light malfunctions indefibrillators made by Guidant, said that he discussed his findings earlier this year withMedtronic officials, who said there was not enough data to come to any conclusions. InMarch, however, the company issued a letter to doctors sharing those concerns withdoctors.
Last month, when 30 months of data showed a continuing fracture problem, Medtronicbegan talking with its independent medical advisers about what to do next. “The numbersthat 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 theadvisory board.
Statistically speaking, there is not enough data to be sure that Fidelis is unusually prone tofracture. But with mounting evidence that there was cause for concern, Medtronic decidedto act now. Five deaths have been linked to the fractures as a possible, though notconfirmed, contributor.
The numbers suggesting that the problem was significant enough to halt sales of the leadcome from two other sources: a clinical trial currently following the progress of 650patients at 17 hospitals and the mountain of data collected from 25,000 patients inCareLink, Medtronic’s system for remotely monitoring implants. Medtronic said that data from fractured leads that have been returned had helped it understand where themalfunctions occur.
Statistically speaking, there is not enough data to be sure that Fidelis is unusually prone tofracture. But with mounting evidence that there was cause for concern, Medtronic decidedto act now. Five deaths have been linked to the fractures as a possible, though notconfirmed, contributor.
The numbers suggesting that the problem was significant enough to halt sales of the leadcome from two other sources: a clinical trial currently following the progress of 650patients at 17 hospitals and the mountain of data collected from 25,000 patients inCareLink, Medtronic’s system for remotely monitoring implants. Medtronic said that data from fractured leads that have been returned had helped it understand where themalfunctions occur.
Federal safety regulators, who participated in the announcement yesterday, endorsedMedtronic’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 DrugAdministration.
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 nowowns Guidant. Sales have slumped in the United States in the last two years because of astring of safety recalls and concern among doctors that it is too difficult to identify whichpatients would benefit from the devices. They can cost $30,000 or more.
Medtronic declined to discuss the potential financial impact of its actions regarding Fidelisprior to a conference call scheduled for this morning with Wall Street analysts. Thecompany, which had $12.3 billion in sales last year, has more than 55 percent of thedefibrillator market, and the devices are its biggest product.
Medtronic will cover the cost of a replacement lead for those that have fractured, plus upto $800 in medical expenses that are not covered by insurance. But the company will notpay for procedures to replace functioning leads that patients want taken out to head offpossible problems in the future, a company spokesman, Robert Clark, said.
Mr. Clark declined to comment on how many unused leads the company expected to takeback and destroy. He said Medtronic would attempt to design a similarly narrow lead toreplace the current products.
Medtronic is recommending that doctors switch back to its older Quattro lead, but doctorswill have other options from other companies. The biggest long-term financial impact onMedtronic could come not from doctors using other leads but from the possibility thatthey could switch to complete defibrillator packages from other companies.
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 meany to ensure a continuoussteady beat.
Mr. Clark declined to comment on how many unused leads the company expected to takeback and destroy. He said Medtronic would attempt to design a similarly narrow lead toreplace the current products.
Medtronic is recommending that doctors switch back to its older Quattro lead, but doctorswill have other options from other companies. The biggest long-term financial impact onMedtronic could come not from doctors using other leads but from the possibility thatthey could switch to complete defibrillator packages from other companies.
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 meany to ensure a continuoussteady beat.
Medtronic developed Fidelis as part of the race among cardiac device companies todevelop ever more compact and flexible products that can be implanted more easily andsafely.
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 toquickly disclose the problems.
Since then, the Heart Rhythm Society, the professional group for doctors who implantdefibrillators, 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 theindustry 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 couldhave continued on the market for a long time, maybe forever,” he said.
Barry Meier contributed reporting.
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