22 septembre, 2005 21:41
Industry
Guidant says two models of pacemakers could fail
Last Updated: 2005-09-22 14:09:25 -0400 (Reuters Health)
CHICAGO (Reuters) - Guidant Corp. said on Thursday it has identified two separate problems with two models of its implantable pacemakers that could lead to device failure.
The problems involve its Insignia and Nexus pacemakers, which treat hearts that beat too slowly. The problems follow a spate of device failures and recalls by the company involving its most lucrative products.
Guidant said the failures could result in sudden, intermittent or permanent loss of pacing, causing serious health complications. No deaths have been reported as a result of the device failures.
Guidant's shares fell 64 cents, or about 1 percent, to $68.85 in morning trading on the New York Stock Exchange.
Guidant said it confirmed one type of failure in 36 out of 49,500 implanted devices. It estimates the potential future failure rate of between 0.017 and 0.037 percent for the 41,000 patients who still have the device implanted.
Guidant said the U.S. Food and Drug Administration has classified the problem as a recall.
It said a second type of problem resulted in 16 device failures out of 341,000 Insignia and Nexus devices distributed worldwide. Guidant said one patient, who was dependent on the pacemaker, experienced fainting and was resuscitated for cardiac arrest after the device failed.
Guidant said an estimated 145,000 devices are active in the United States. It said the FDA may classify this problem as a recall. Guidant recommends doctors verify pacemaker operation in the packaging before implanting the device.
Guidant said the FDA inspected its heart device plant in St. Paul, Minnesota, and provided it with a list of problems, including observations about the two pacemaker brands noted in the physician advisory.
