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Health Highlights: Aug. 17, 2012

FDA Orders Heart Device Maker to Study Defective Component

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

FDA Orders Heart Device Maker to Study Defective Component

The U.S. Food and Drug Administration on Thursday ordered medical device maker St. Jude Medical to conduct further studies on patients who received heart-device components that were subject to recall last year and have been tied to up to 20 deaths.

According to The New York Times, the FDA is also ordering that patients undergo X-rays or other scans to check for trouble with the Riata lead, a wire that connects a defibrillator to the patient's heart. The lead, which was discontinued in 2010, may be faulty because wires within the lead can break through the protective outer sheath and inadvertently shock patients. Defective leads might also prevent the defibrillator from working when needed, the Times said.

Over 128,000 patients around the world use the Riata lead, the Times said, and St. Jude last year sent an alert to doctors warning of the issue and saying it would investigate. The FDA on Thursday advised that doctors check patients for abnormalities in the insulation around the lead but, like St. Jude, the agency advised against routinely removing the leads.

"It is important to note that in published studies, the majority of leads with externalized conductors have continued to function properly," the company said in a statement.

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