More Guidant heart device failures reported- FDA

WASHINGTON (Reuters) – U.S. regulators said on Thursday
they had received 21 reports of device failures, including
three deaths, linked to some Guidant Corp. implanted heart
defibrillators as of October 7.

The Food and Drug Administration said six of the cases had
been reported after the agency issued a public health advisory
on July 14. The problems occurred with Guidant’s Contak Renewal
and Renewal 2 devices.

“You should take these failures into account as you
continue to follow the patients who retain either device,” the
FDA said in a note to doctors posted on the agency Web site at
http://www.fda.gov/cdrh/safety/101305-guidant.html.

According to information on Guidant’s Web site, the company
disclosed the same figures in a report posted there on
September 19.

Guidant has reported problems with several implanted
defibrillator and pacemaker models during recent months.

Shares of Indianapolis-based Guidant, which is being
acquired by Johnson & Johnson, fell 42 cents, or 0.59 percent,
to $70.90 in afternoon trading on the New York Stock Exchange.