Company Warns Doctors of Possible Pacemaker Problem

By Karren Mills Associated Press Writer

MINNEAPOLIS (AP) - The nation's second largest pacemaker manufacturer said Wednesday at least 90 of its pacemakers being used by heart patients could malfunction and stop emitting the electrical signal that regulates their heartbeat.

Problems had been reported in 33 of St. Jude Medical Inc.'s 35,000 Affinity pacemakers, spokesman Peter Gove said. Of the 891 pacemakers that St. Jude has identified as potentially having the problem, about 90 are affected, Gove said.

He said the company was unaware of any patient injuries, and the problems weren't severe enough to warrant immediate removal. The company, which is based in Little Canada, Minn., did send letters to doctors to inform them of the problem.

"For the vast majority of patients, all their doctor will do is continue to monitor them. If the problem presents itself, they will then decide whether to replace the pulse generator," Gove said.

The model numbers are 5130, 5230 and 5330.

The pacemaker is implanted in a pocket under the skin in the pectoral muscle. Gove said replacing the pulse generator typically is outpatient surgery and the company would pay up to $800 of any patient's unreimbursed medical expenses for replacing it.

The U.S. Food and Drug Administration has been advised of St. Jude's letter to doctors, Gove said.

Pacemakers help patients with slow heartbeats. Normally the condition is not life-threatening. However, a small number of patients are dependent on their pacemakers and could die if the device stops working. About 300,000 St. Jude pacemakers are in use in the United States.

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-- Carl Jenkins (Somewherepress@aol.com), February 16, 2000

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Research; [fair use: FERPO] The *quality-speed-to-market enhancements may require further refinements, huh? -> DESCRIPTION St. Jude Medical Announces CE Mark Approval for Affinity Pacing System -> CONTACT -> TEXT St. Paul, MN, September 24, 1998 -- St. Jude Medical, Inc. (NYSE:STJ) today announced that it has received approval for CE marking of the Pacesetter Affinity DR (dual-chamber) and Affinity SR (single-chamber) pacemakers and related software. The Company is currently implanting devices and plans a full market release outside the United States during fourth quarter 1998.

Our Affinity pacing system is the first family of products to benefit from our reengineered product development process, stated Daniel J. Starks, CEO and President of the Cardiac Rhythm Management Division. Less than a year ago, we formed a dedicated cross-functional team to coordinate the final stages of Affinity device and software development. Now, only eleven months later, the Affinity system is commercially available in Europe. Clearly, the initiatives we have implemented to enhance *quality-speed-to-market are yielding impressive results.

Featuring the clinically proven AutoCapture pacing system and Omnisense accelerometer sensor, Affinity pacemakers are designed to provide highly individualized automatic therapy that is simple to manage and cost-effective. Device performance is further enhanced by the APS. III Patient Management System, which offers high-speed processing, the industrys most comprehensive diagnostic capabilities, and many new customer-focused software refinements.

The AutoCapture pacing system is intended to ensure patient safety while maintaining the lowest possible energy output. This revolutionary technology features beat-by-beat confirmation of capture (successful cardiac stimulation), a high-output back-up pulse to stimulate a heartbeat if capture is lost, periodic measurement of pacing threshold, and automatic regulation of energy output to slightly above the measured threshold. St. Jude Medical is the only pacing company to offer the security of a back-up safety pulse in conjunction with very efficient energy output management to promote device longevity, which is estimated at over 10 years for the Affinity DR pacemaker at typical settings with AutoCapture programmed on.

In Europe we have seen the Pacesetter AutoCapture pacing system benefit thousands of patients implanted with the single-chamber Microny or Regency pacemaker, said Reto Candinas, M.D., who implanted one of the first Affinity DR pacemakers last month at Universitdtsspital Z|rich in Switzerland. Now we can offer patients truly automatic dual-chamber pacing therapy.

Dr. Candinas continued, Early clinical experience with the Affinity DR pacemaker is showing that the AutoCapture pacing system is highly effective in a dual-chamber device. Patient thresholds at implant have ranged from 0.5 to 0.75 volts, resulting in ventricular outputs of 1 volt or less. In combination, the automatic titration of output and the back-up safety pulse assure appropriate safety margins and efficient pacing with minimal effort on the part of the physician.

The Company submitted a PMA supplement for the Affinity DR and SR pacemakers and associated software to the U.S. Food and Drug Administration on July 29, 1998, and anticipates U.S. commercial distribution of the devices during the first quarter of 1999.

-> RELEASEDATE

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-- Michael (mikeymac@uswest.net), February 16, 2000.