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FDA investigating Medtronic

Jan 1, 2007 |

The Food and Drug Administration is investigating the medical device maker Medtronic, reportedly over its recently launched Concerto implantable defibrillators.

FDA spokeswoman Heidi Rebello confirmed that the agency is investigating Medtronic, but declined to go into detail. The Wall Street Journal first reported on Tuesday that the FDA was investigating allegations from a former Medtronic engineer that the company did not adequately test its Concerto device prior to launch.

The Minneapolis-based device maker put 11,000 Concerto devices on the U.S. market after the FDA approved it in May of 2006, said Medtronic spokesman Robert Clark. But Clark said the FDA has not discussed the investigation with Medtronic.

"Medtronic has not been contacted by the FDA in regards to an investigation in this matter," said Clark.

The Medtronic spokesman said his company had fully considered all the concerns and suggestions from the product development engineer, and acted on some of them.

"Some of the suggestions he raised were, in fact, implemented," said Clark. "In other areas though, we found that his concerns had no merit."

The implantable Concerto device works by sending mild shocks to the heart when it begins beating abnormally, to jolt the muscle back into a normal rhythm. Clark said the device includes a wireless transmission system with a backup to send patient's data to their physicians.

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