pacemakers

FDA says CT scans can make medical devices malfunction

Anne Zieger — Tue, 15 Jul 2008 09:39:22 -0400

The FDA has issued a warning that some critical electronic devices may malfunction when patients get CT scans. In fact, CT scans may actually cause some medical devices to shock patients using them, or send out inaccurate signals, the agency said. This squares with an earlier study, published by Mayo Clinic researchers, which found that CT scans often interfered with electronic heart devices. Devices on the FDA's warning list include pacemakers, defibrillators, insulin pumps, neurostimulators, drug infusion pumps, cochlear implants and retinal implants. To date, the FDA has received six confirmed reports of devices that malfunctioned after CT scans, as well as another nine reports of suspected problems, though no deaths have occurred to date.

To learn more about the alert:
- read this Chicago Tribune article

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FDA to tighten medical device safety regs

Sun, 12 Nov 2006 19:01:37 -0500

The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. The move was prompted, in part, by concerns over last year's massive defibrillator recalls, which concerned more than 200,000 devices. Among other steps, the FDA would like to see devices marked with a unique number, making it easy to track them during recalls. It also plans to begin using data-mining techniques to detect potential problems, and collect real-time safety data from government and private hospitals.

Find out more about the upcoming regulations:
- read this Associated Press piece

ALSO: When patients with implantable defibrillators die, most are buried with the devices still in their chests despite the fact that they could be returned to the manufacturer. Report

Boston Scientific announces recall, shares drop

Mon, 26 Jun 2006 20:01:36 -0400

Boston Scientific said it will recall one of its pacemaker models after an FDA report released last week suggested many of the units will eventually malfunction. The device maker's shares fell seven percent on the news Monday and are down midday Tuesday. CEO Jim Tobin said in a conference call that it may take 18 months to two years to correct problems with the pacemakers and defibrillator lines the company acquired in the Guidant deal this year. He also hinted the recall may not be the last.

Boston Scientific has also been hurt by a report published in The Wall Street Journal last week that suggested leading cardiac centers are moving away from using its drug eluting stents. Not everybody agrees with the interpretation, but the report has raised another potential concern for investors.

- read this article from the Houston Chronicle

SPOTLIGHT: Medtronic wins FDA approval for Concerto

Thu, 18 May 2006 20:01:33 -0400

With potential device failure very much in the public eye after last year's recalls, it seems logical that technology which allows doctors to remotely keep tabs on how pacemakers and defibrillators are performing would be popular. That's probably good news for Medtronic: The company won FDA approval for its Concerto/Virtuoso line of implantable defibrillators, which allow wireless data transfer from the devices via patient home monitoring units. Article

CMS mulls reimbursement cuts for cardiac devices

Sun, 16 Apr 2006 20:01:36 -0400

CMS is considering reducing Medicare reimbursements for implantable heart devices, a change that could be a painful hit for specialty hospitals and device makers, if it does in fact go through. The cuts would impact some of the most lucrative heart device categories on the market, including pacemakers, defibrillators and stents. CMS officials say the changes are necessary to eliminate loopholes that specialty hospitals had been exploiting. The agency is weighing reducing payments for stents by more than 30 percent and defibrillators by around 20 percent. Under the proposed rules, by 2008 cardiac hospitals will suffer an 11.7 percent reduction in payments; orthopedic centers, a 9.4 percent decline; and surgical hospitals, a 7.2 percent drop.

- see this article from the Wall Street Journal

FDA to monitor heart device safety

Thu, 06 Apr 2006 20:01:37 -0400

The FDA said it will set up a team of outside medical experts to study the safety of heart devices currently on the market. The decision is a step in a new direction for the agency, which has historically relied on internal advisory panels to review the safety of drugs and medical devices. The announcement comes days before the release of a report by the Heart Rhythm Society, an influential cardiologists group, which is expected to recommend major changes in the way safety issues are handled. The FDA's oversight of medical devices has remained a hot issue in Washington since last year when Guidant recalled thousands of potentially dangerous defibrillators and pacemakers after it was learned that they contained a manufacturing defect that caused them to short circuit in some cases.

- see this article from The New York Times

Panel chastises Guidant over recall

Mon, 20 Mar 2006 19:01:36 -0500

An independent review panel sharply criticized Guidant for its past handling of patient-safety issues. The panel said the company's response to evidence of serious defects involving its pacemakers and defibrillators was inappropriate. Guidant executives learned of the problems three years ago, but chose not to release the information. The group's report finds the company relied on engineers to make decisions about the release of safety information rather than turning to medical experts. The review was led by Dr. Robert J. Myerburg of the University of Miami.

- see this article from The New York Times

Lawsuit data reveals turmoil at Guidant

Mon, 27 Feb 2006 19:01:37 -0500

Last year, just as it was putting itself up for sale to J&J, device maker Guidant was the feature of a series of articles in The New York Times in which it was accused of poorly communicating about problems with its pacemakers to physicians. Eventually, several pacemakers were recalled. Note that replacing a pacemaker means expensive and painful surgery, so this was not a trivial decision.

Now the Times features some of the discoveries from one of a number of lawsuits concerning the recall, revealing that the company knowingly sold devices that were faulty and kept doctors (not to mention patients and regulators) in the dark about what the company knew and when it knew it. Guidant was eventually sold to Boston Scientific, which has inherited the aftermath of those problems, and--given its history of stent recalls-- knows something about production problems.

- read the article in The New York Times

The FDA warns Boston Scientific

Thu, 26 Jan 2006 19:01:36 -0500

The FDA warned Boston Scientific that quality control problems at six of its manufacturing facilities still need to be addressed. The FDA warned the company has not fixed "continuing serious deficiencies." In the worst case scenario, the warning could mean that the device maker might be prevented from introducing new products until changes are made to correct the problems. The warning came only hours after Boston Scientific closed its $27.2 billion merger with Guidant on Tuesday. Some analysts think the news could impact the transaction, noting that a drop in the price of Boston Scientific's shares might affect the company's ability to close the deal.

- see this article from The Boston Globe

ALSO: A look at just how bad things were over the last quarter at Guidant after its recalls: Defibrillator sales were down 19 percent, and pacemakers were down 24 percent. Article

Guidant bid deadline approaches for J&J

Mon, 23 Jan 2006 19:01:39 -0500

Johnson & Johnson has until today to raise its offer for Guidant. Many analysts think its unlikely J&J will fork over more than the $24.2 billion it has already offered to beat a larger bid from Boston Scientific. But on the other hand, it is increasingly obvious how important Guidant's business could be to the company's future. J&J turned in final results for 2005 today, reporting so-so drug sales but great numbers from its medical device and diagnostic services units, with sales up 13.1 percent to $19.1 billion in the fourth quarter. Cypher stent sales were up about 10 percent. Sales of orthopedic products were equally impressive. What's a nice little medical products and services giant to do? Pay up, perhaps.

- see this article from the Wall Street Journal (sub. req.)

ALSO: To make the plot a little more interesting, Guidant announced that it is broadening its earlier recall of cardiac rhythm management devices. The company now says as many as several thousand of its pacemakers and defibrillators may need to be removed from patients. Units affected include the Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II and Contak TR. Article