Heart Pacemakers

At 14 years old, Nicky is no spring chicken. And so it was not surprising that the Australian shepherd was having heart problems. On Wednesday night, however, Nicky's heart became particularly agitated and her owner, William Hipp, took Nicky to a Garden Grove animal emergency hospital. There, the veterinarian on duty thought the dog should be seen by a specialist. After conducting a series of ultrasound tests, the specialist determined that Nicky needed a pacemaker if she was to survive.

Millions of Americans receive implanted cardiovascular devices such as pacemakers and stents, but many of the devices are not subjected to rigorous safety and effectiveness research before being approved for use, according to a study released Tuesday. It's common for such devices to receive Food and Drug Administration approval based on information from only a single study, which "raises questions about the quality of data on which some cardiovascular device approvals are based," said the authors, from UC San Francisco.

A recall by Guidant Corp. of certain heart pacemakers has been classified as the most serious type of recall, the Food and Drug Administration said. Guidant's action, announced July 18, was deemed a Class 1 recall, reserved for when there is "a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death."

Boston Scientific Corp. said Thursday that three of its subsidiaries agreed to pay $16.75 million and extend the warranty on some of its heart devices as part of a settlement with state attorneys general over defibrillator recalls. The affected devices were manufactured by Indianapolis-based Guidant Corp., which Natick, Mass.-based Boston Scientific acquired last year.

Four former Cordis Corp. officials were found innocent in federal court Friday of selling defective heart pacemakers between 1983 and 1985. All have left the Miami-based company, which has since sold off its pacemaker division. Cordis itself had pleaded guilty previously and paid a $764,000 fine, along with $5 million in civil penalties, to various federal agencies.

Cordis Corp. today pleaded guilty to charges that it sold defective heart pacemakers and corrosion-prone batteries and agreed to pay $764,000 in fines and costs. Cordis general counsel Daniel G. Hall entered the plea on the company's behalf to 12 felonies and 13 misdemeanors, including fraud and false labeling.

Boston Scientific Corp. on Monday recalled nearly 23,000 heart pacemakers and defibrillators that could fail because of an electrical flaw, and the company asked doctors to check 27,000 patients who had been implanted with potentially faulty devices. The announcement marked the second time Boston Scientific has warned about products of the former Guidant Corp. since the Natick, Mass.-based company bought Guidant in April for $27 billion. Shares of Boston Scientific fell $1.

In mid-August, Siemens-Pacesetter Inc., a Sylmar manufacturer of heart pacemakers, got federal approval to start selling its latest pacemaker, the Synchrony. The device, which costs doctors $6,300, is the most sophisticated and expensive pacemaker Siemens-Pacesetter has yet designed. Chairman Alfred E. Mann believes that Synchrony will enable his company, the industry's No. 2 player with about 25% of the $1.

Apple Inc.'s iPods can cause cardiac implantable pacemakers to malfunction by interfering with the electromagnetic equipment monitoring the heart, according to a study presented by a 17-year-old high school student at a meeting of heart specialists. The study tested the effect of the portable music devices on 100 patients, whose average age was 77, who were outfitted with pacemakers.

European scientists have successfully implanted a tiny pacemaker into several patients to control high blood pressure -- and report reductions that surpass what medicines have been able to do for these patients. "This has tremendous potential," said Dr. Frank Veith, a professor of surgery at New York University School of Medicine who runs the Veith Symposium, an annual scientific meeting at which the results were reported.

Boston Scientific Corp. on Monday recalled nearly 23,000 heart pacemakers and defibrillators that could fail because of an electrical flaw, and the company asked doctors to check 27,000 patients who had been implanted with potentially faulty devices. The announcement marked the second time Boston Scientific has warned about products of the former Guidant Corp. since the Natick, Mass.-based company bought Guidant in April for $27 billion. Shares of Boston Scientific fell $1.

Medical device maker Guidant Corp. on Monday expanded its pacemaker recall, saying seals in some models failed at a higher rate than originally reported and that thousands of other devices could have the same problem. The news came as Guidant waited to hear from Johnson & Johnson, which faces a deadline today to respond in its bidding war with Boston Scientific Corp. for the Indianapolis-based company.

Medtronic Inc., the world's biggest maker of electronic heart devices, said it was notifying doctors about a potential defect in certain Sigma series pacemakers after some patients said they felt dizzy or fainted. No deaths or injuries were reported, a spokesman for Minneapolis-based Medtronic said. About 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory.

Guidant Corp. issued recalls or safety advisories for almost 170,000 of its top-selling pacemakers Thursday after a two-week federal inspection of its cardiac unit. Since June, Indianapolis-based Guidant has recalled or issued warnings for about 88,000 implanted defibrillators -- including its leading seller, the Contak Renewal 3 -- and almost 200,000 pacemakers because of reported malfunctions.

A faulty heart pacemaker wire has been blamed for two deaths, prompting a meeting between federal regulators and the manufacturer concerning 40,500 people worldwide who have the device in their chests. Food and Drug Administration officials and executives from Telectronics Pacing Systems Inc. in Englewood, Colo., will try to determine whether surgery would be more risky than leaving the devices intact. "We're concerned," Bruce Burlington of the FDA said Thursday.

Many brothers spend their teen-age years at one another's throats, but not 16-year-old Dustin Petok and his 19-year-old sibling, Josh. They enjoy each other's company, make home movies together and often team up to play jazz, Dustin on piano and Josh on guitar. There is something else unusual about the San Fernando Valley residents: Both have pacemakers. In fact, the Petoks may be the only teen-age brothers in the United States who have the heart-stimulation devices.

A recall by Guidant Corp. of certain heart pacemakers has been classified as the most serious type of recall, the Food and Drug Administration said. Guidant's action, announced July 18, was deemed a Class 1 recall, reserved for when there is "a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death."