Pacemaker/Defibrilator - Guidant Recall

[M&M]

Hi, I thought I would let those who have a Guidant ICD see this article that I saw posted on the Zapper website:

Guidant recalls some ICDs after failures, deaths
17 Jun 2005 21:44:19 GMT

Source: Reuters

(Adds physician and trader comment, after-hours quotes.)

By Debra Sherman

CHICAGO, June 17 (Reuters) - Guidant Corp. <GDT.N> said on Friday that two reported deaths have been linked to some of its implantable heart defibrillators and it is recalling those and other similar models from the market.

The cardiovascular device company, which agreed to be acquired by Johnson & Johnson <JNJ.N>, said there have been 15 failure reports and one death linked to its popular Contak implantable heart defibrillator and 28 failure reports and one death tied to its Ventak defibrillator.

Shares of Guidant fell in after-hours trading, a decline some traders attributed to concern that J&J's $25.4 billion deal might be in danger.

After the close of trading on Friday, J&J issued a press release saying it continues to work toward closing the deal in the third-quarter. Representatives for the company were not immediately available to comment and Guidant declined to comment further.

Stop-watch-size implantable heart defibrillators, used to shock irregular heartbeats back to normal rhythms, can develop an internal short circuit without warning, resulting in failure to deliver the shock when needed, the U.S. Food and Drug Administration said in a news release.

The agency said it will classify the problems with the Guidant devices as recalls. It did not make a recommendation on whether individual patients who have one of the devices should have it removed or replaced.

The Guidant devices include Ventak Prizm 2 DR, manufactured on or before April 16, 2002; Contak Renewal and Contak Renewal 2 CRT-Ds, manufactured on or before Aug. 26, 2004; Ventak Prizm AVT; Vitality AVT; and Renewal 2 AVT and Renewal 4 AVT ICDs.

In a letter to doctors dated May 23, Guidant had warned that a line of its ICDs contains a flaw that has caused a small number of them to malfunction, but it did not recommend the products be replaced.

The company recommended that patients with the devices continue normal follow-up visits at three-month intervals.

Anne Curtis, an electrophysiologist and president of the Heart Rhythm Society, said checking patients at least every three months would be prudent.

"You have to weigh the possible complications and risks ... when you recommend wholesale replacements of the devices," she said.

Characterizing the events leading to the recall as "serious matters," J&J said in its statement that it was engaged in discussions with Guidant to help it "understand the issues."

"People read that (statement) as an indication that (J&J) is trying to distance themselves from Guidant," said one arbitrageur, who asked not to be named.

Guidant shares fell to $70.90, their lowest level in more than five months, on the Inet electronic brokerage system, from a close of $72.46 on the New York Stock Exchange. J&J shares closed 26 cents higher on the NYSE at $66.56.




I just thought I would share this information..
If you want more articles - www.zaplife.org - and go to the BBS forum there are lots of articles. Since the FDA has made a new ruling on this today.

I have the device in question Ventak Prism - I've been keeping a close eye on this and trying to decide if I should get it replaced or wait till my battery goes dead - and since the news just broke this afternoon I thought perhaps there might be others out there with this brand and 'type' of device that are on the recall list. If your not sure and you have a Guidant ICD - you can call Guidant and ask. Or call your doctor and make them aware. My doc - said he haven't even heard the news - and then he said: Marilyn you certainly stay right on top of things. He'll check it out and get back to me - isn't that NICE.. I saw him just yesterday and I 'was' going to wait and get a Medtronic when my Guidant battery died - but with an FDA recall - I think I may just take another Guidant and I may risk my chances with surgery...

Take Care
Marilyn (runner)

 

[Marguerite53]

Yes, and this in the NYTimes

Yes, and this in the NYTimes

There have been several articles in the New York Times as well...

Citing Flaws, Maker Recalls Heart Devices
?
By BARRY MEIER
Published: June 18, 2005
The Guidant Corporation said yesterday that it was recalling about 29,000 implanted heart devices because of flaws that might cause them to short-circuit when they are supposed to deliver a potentially life-saving shock.
The recall, which comes at the urging of the Food and Drug Administration, involves three models of defibrillators made by Guidant. In the case of one model, the Ventak Prizm 2 DR Model 1861, Guidant did not tell doctors for more than three years that it was prone to electrical failure because of a design flaw. The company also disclosed yesterday for the first time that two other Guidant units had also repeatedly short-circuited.
The company said it was aware of two recent deaths involving the units at issue. It is not clear how much the recalls may cost Guidant.
While the action is technically a recall, it will be up to patients and their doctors to decide whether to undergo surgery to replace the affected devices. Such decisions are typically based on the age and health of a patient and the physician's assessment of a device's risk.
The recall comes as F.D.A. officials continue their review of Guidant's handling of issues surrounding the products, particularly the Prizm 2 DR. The other models are the Contak Renewal and Contak Renewal 2, which are more complex defibrillators intended for patients with severe heart failure.
The F.D.A. urged affected patients to contact their doctors but did not take a position on whether the devices should be replaced.
Defibrillators are surgically implanted in the chest under the skin. If the heart is beating chaotically, the defibrillator emits an electrical jolt in an effort to restore it to normal rhythm.
In a statement yesterday, Ronald W. Dollens, chief executive of Guidant, said the company was taking the actions because it wanted to share information about problems "in a small subset of Guidant devices."
Guidant said it would provide free replacements for the devices, which can cost up to $25,000. "We will work with physicians as they decide how best to treat their patients," Mr. Dollens added.
But yesterday's disclosure that Guidant also knew that other popular company models beside the Prizm 2 were prone to short-circuiting raises further questions about how the company handled such issues.
An F.D.A. official also questioned whether Guidant had acted properly when it recently rushed out a letter to doctors notifying them that the Prizm 2 had short-circuited in over 25 known cases, including the March death of a 21-year-old student.
The company took the action late last month when it became aware that problems with the device, which date back to 2002, were going to be publicized in other forums.
Tim Ulatowski, the director of the agency's Center for Devices and Radiological Health, said Guidant should have treated the matter as a recall at that time.
Johnson & Johnson, which announced a plan in December to acquire Guidant for $25.4 billion largely to gain its cardiac device unit, issued a statement yesterday saying that while it continued to work to complete the deal, it was concerned about the developments. Last year, Guidant had $3.8 billion in sales, about half from implantable defibrillators.
"The events reported by Guidant are serious matters, and Johnson & Johnson is engaged in discussions with Guidant to help the company understand the issues," the statement read.
In trading on the New York Stock Exchange, shares of Guidant fell 84 cents a share to close at $72.46 a share.
Guidant has said it does not recommend that doctors replace the Prizm 2 model because it is reliable and because the additional surgery poses extra risks.
In April 2002, the company changed the way it manufactured the device to eliminate the electrical flaw. It has said it has not received similar complaints about devices made after that date. About 17,000 devices made before April 2002 are still implanted in patients, 13,900 of them in this country.
In the case of the Contak Renewal and Renewal 2 models, Guidant also urged that physicians closely follow how well the device is functioning, but did not make a recommendation one way or the other regarding replacement. Along with a defibrillator, the units have pacemaker functions that regulate beating for both sides of the heart.
The company said that internal testing showed that the failure rate of Renewal products might increase over time from a current rate of 0.09 percent to a range of 0.2 percent to 0.6 percent. About 11,900 Renewal products are still implanted in patients worldwide, about 6,700 of them in this country.
In February, another defibrillator maker, Medtronic, notified doctors that the battery used in one of its models was draining far faster than expected. It said the problem could become worse over time and affect 0.2 percent to 1.5 percent of its units. About 13,000, or 15 percent, of the 87,000 patients implanted with the device have had it replaced.
In many respects, the issues and Guidant's actions in the cases of the Prizm 2 and Renewal models parallel each other.
After the March death of a college student, Joshua Oukrop, doctors in Minnesota learned from Guidant that the Prizm 2 defibrillator they had implanted in him in 2001 had a history of electrical failures related to a design flaw.
The physicians, who had been treating Mr. Oukrop for a genetic heart disease that put him at risk of sudden cardiac arrest, said they urged Guidant at that time to notify other doctors. But company officials said they did not plan to do so because they did not see the problem as significant. The company did send a letter to doctors about the device in late May just as The New York Times was publishing an article about the Prizm 2.
In the aftermath, the F.D.A. began reviewing Guidant's handling of the matter. It was during that process that agency officials began to look at the Renewal devices, said Mr. Ulatowski, the F.D.A. official.
"We always inquire whether a problem caused by a design problem in one product might exist in other products," he said.
Mr. Ulatowski added that Guidant, through a filing, had notified the F.D.A. about manufacturing changes it made last August to correct a short-circuiting problem in the Renewal models.
However, only during recent reviews did the agency become aware of the scope of the problem. While Guidant previously received 14 reports of electrical failures in Renewal devices produced before August, it received a report on May 30 of the death of a patient who had been implanted with a unit that failed in a similar way.
It also appears that Guidant may have continued to sell older Renewal models in its inventory after improved versions were available, as it had done with the Prizm 2 defibrillator. Yesterday, Guidant officials declined to comment about the issue.
Since the controversy over the Prizm 2 began, Guidant has insisted that it made all required reports to the F.D.A. about device problems.
But under agency guidelines, the company was also required to undertake an internal assessment of the patient risks posed by the device's electrical problems once it discovered them.
Such an analysis must include an evaluation of how frequently the flaw is likely to occur, its danger and whether doctors and patients would become aware of it as a result of mechanisms in the device, like a beep that indicates the battery is dying.
Mr. Ulatowski, the F.D.A. official, said the agency was still reviewing Guidant records. "We are taking a very careful look at the events that occurred and what decisions were made or were not made," he said.
Guidant has acknowledged that because the flaws involved a short-circuiting of a device while it was charging to deliver a high-voltage shock, it could occur unpredictably.
A group that represents doctors treating heart patients, the Heart Rhythm Society, is expected to soon set up a task force to press for standards governing device makers' notifications of doctors about problems with implanted heart units. In his statement yesterday, Mr. Dollens, the Guidant chief executive, said he supported that effort.
In addition to the Prizm 2 and the two Renewal models, Guidant said yesterday that it was recalling 21,000 other defibrillators that had a programming error that might affect device performance. The company said patients could have the device reprogrammed during their next regular doctor's visit.
Guidant said the affected units were the Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT.

 

[Phyllis]

June 25th NY Times

June 25th NY Times

--------------------------------------------------------------------------------

June 25, 2005
Guidant Says Flaw Is Found in More Types of Heart Units
By BARRY MEIER
The Guidant Corporation, already under scrutiny for delaying disclosures about flawed products, urged doctors yesterday to stop implanting its most sophisticated heart devices because of a fault that might cause some of the 40,000 units already implanted not to work properly.

The move could have significant financial consequences for Guidant because it affects, for now, sales of many of the company's heart devices in the fastest-growing part of the market: advanced defibrillators that also act as pacemakers for both sides of the heart.

Yesterday, the company's stock fell $4.70, or 6.85 percent, to $63.90 as investors grew nervous over the fate of Johnson & Johnson's plan to acquire Guidant for $25.4 billion.

Analysts said they thought Johnson & Johnson would probably cut that price. They also said the deal's planned closing in the third quarter of this year might be delayed. They added that the products involved in yesterday's move appeared to account for a substantial percentage of Guidant's defibrillator sales.

Both Johnson & Johnson and Guidant had no comment and declined to make their top executives available for interviews.

The flaw at issue in yesterday's announcement involves a magnetic switch that becomes stuck in the off position. For patients, the flaw poses less of a risk than some defects affecting other Guidant devices, doctors said. However, they said users would have to see physicians so they could disable the problem component.

As proposed partners, Johnson & Johnson and Guidant have provided very different case studies of corporate responses to product problems.

Johnson & Johnson, based in New Brunswick, N.J., withdrew all bottles of its pain reliever, Tylenol, from store shelves in 1982 after reports of product tampering. The company won praise at the time for its quick response.

Guidant's problems began in late May, when it was disclosed that the company, based in Indianapolis, had not told doctors for three years that one type of its defibrillators had repeatedly failed because of an electrical defect. A defibrillator emits an electrical jolt that shocks a chaotically beating heart back into rhythm.

Since then, the device maker has been buffeted by bad publicity because it has been forced to make repeated announcements about other device-related defects. Late last week, under pressure from the Food and Drug Administration, Guidant recalled 50,000 defibrillators, with thousands of them at risk of potentially short-circuiting just when needed to produce a life-saving shock.

"One thing that distinguishes this recall from others is the time gap from when it was discovered and when it was disclosed," said Alexander Arrow, an industry analyst with Lazard. "It points to a corporate response that looks inappropriate, so that it potentially has more staying power on the reputational level."

Yesterday's announcement by Guidant affects several models: the Contak Renewal 3; Contak Renewal 4; Contak Renewal 3 and 4 AVT; and the Renewal RF. The company said it had received four reports of flawed switches among the 40,000 units implanted.

However, the financial impact on Guidant could be substantial, at least in the short term, because the affected models appear to involve many of the company's advanced defibrillators. The use of such devices, which cost about $25,000 each, is growing rapidly in part because Medicare has greatly increased the number of older patients for whom it will pay for such devices. The units are used in patients who are at risk of cardiac arrest and have other heart problems.

Dr. Eric N. Prystowsky, a heart specialist at St. Vincent Hospital in Indianapolis and a Guidant consultant, said company officials alerted him late Thursday about yesterday's announcement and told him they would pull back all affected units that had not been implanted, a number the company put at 6,000. As a result, he said, he would be using other companies' units for the moment.

The company did not say how it planned to fix the problem, when it expected to do so or how it would fix units already implanted in patients. If a significant change must be made in the way units are made, the change could require F.D.A. approval before Guidant could make new units.

Dr. Prystowsky said that until the problem was fixed, Guidant technicians might have to be on hand when patients were prepared for surgery so the technicians could deal with the affected magnetic switch.

Guidant does not break out its sales by model types, but last year, defibrillator sales accounted for nearly 50 percent of its revenue of $3.8 billion. Analysts said they thought the types of models involved in yesterday's alert, which are known as cardiac resynchronization therapy, or C.R.T., devices, made up 40 percent to 50 percent of its defibrillator sales.

C.R.T. devices are the fastest-growing part of the defibrillator market, which is expanding 20 percent annually. Guidant's heart device division was a major attraction to Johnson & Johnson, which wants to expand its presence in the device business.

Joanne Wuensch, an industry analyst with Harris Nesbitt, said she believed that the financial effect of the latest alert on Guidant would be relatively short-lived. But she said she thought Johnson & Johnson would soon cut the price it was offering for Guidant. As it stands, that deal is valued at $76 a share to Guidant holders.

"We estimate it is going to be about $68 a share, or about 10 percent down," she said. Mr. Arrow, the Lazard analyst, also downgraded Guidant on Monday.

Johnson & Johnson did not respond to a request to interview its chief executive, William C. Weldon. Guidant declined a request to interview its chief executive, Ronald W. Dollens. Guidant also would not say what percentage of its defibrillator sales were affected by the faulty switch.

While Guidant's shares sank yesterday, shares of its two rivals, Medtronic and St. Jude Medical, both rose, apparently in anticipation that their market share would increase, at least in the short term. A Guidant spokeswoman said the company was "ramping up" manufacture of two other C.R.T. models, the Contak Renewal 1 and Contak Renewal 2.

Dr. Prystowsky said he thought the company had moved quickly yesterday to halt implants of any further devices with the flawed switch, given the controversy after it did not alert doctors to an electrical flaw in one model. In that case, a college student who had been implanted with one of the flawed units died in March, three years after Guidant discovered and fixed the problem.

"They said we have heard everyone loud and clear," he said. "We are willing to take the economic hit."



Copyright 2005 The New York Times Company Home Privacy Policy Search Corrections XML Help Contact Us Work for Us Back to Top