Officials at Guidant Corp. projected that as many as 15 of every 10,000 of its Prizm 2 DR implantable heart defibrillator might fail per year, leading to death in some cases, but did not tell doctors or regulators about the problems, according to documents filed in a Texas state court.
Don't miss these Health stories
More women opting for preventive mastectomy - but should they be?
Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.
- Larry Page's damaged vocal cords: Treatment comes with trade-offs
- Report questioning salt guidelines riles heart experts
- CDC: 2012 was deadliest year for West Nile in US
- What stresses moms most? Themselves, survey says
- More women opting for preventive mastectomy - but should they be?
The documents show the company estimated that the effects from short circuits in its Prizm 2 DR device could be life-threatening in about 12 percent of those cases, The New York Times reported Saturday.
The Guidant documents were filed Thursday in a Texas state court in Corpus Christi by attorney Robert C. Hilliard, who is representing plaintiffs who sued Indianapolis-based Guidant, claiming it failed to warn them about the possible defects.
A Guidant spokesman did not immediately return a call Sunday seeking comment. The company said in an e-mail to the newspaper that it does not comment on pending litigation.
In addition, New York State and the city of Bethlehem, Pa., have sued Guidant seeking reimbursement for device-related health care costs.
One of the records shows the company estimated that about 15 units out of every 10,000 were likely to short-circuit, the newspaper reported, citing the documents. Of those, about one in 10 would experience either death or a life-threatening episode.
Since June, Guidant has recalled or issued warnings about 88,000 heart defibrillators and almost 200,000 pacemakers because of reported malfunctions. The company is under investigation by federal and state officials and faces dozens of lawsuits over its recalls.
Copyright 2005 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.