FDA finds no fault with Medtronic heart device

NEW YORK (CNNMoney.com) -- The Food and Drug Administration said it completed an investigation of Medtronic over its recently launched Concerto implantable heart devices but hasn't found anything to indicate that the devices are unsafe.

FDA spokeswoman Heidi Rebello confirmed that the agency investigated Medtronic based on a former employee's allegations about the devices, known as defibrillators.

"[The] FDA took the allegations made by the former Medtronic employee very seriously," Rebello wrote in an e-mail to CNNMoney.com. "The agency has completed a thorough investigation of the charges."

The FDA's safety investigation included a review of the allegations and an inspection of the plant where the Concerto devices are made, Rebello said in the e-mail. "To date, [the] FDA has found nothing that would have influenced its decision to approve this device," she wrote.

The Wall Street Journal first reported 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 the device last May, Medtronic spokesman Robert Clark told CNNMoney.com Tuesday.

But Clark 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.

Medtronic's (down $0.31 to $52.81, Charts) stock edged lower in morning New York Stock Exchange trading.

Medtronic is one of the lead medical technology companies, competing with Boston Scientific (down $0.35 to $18.24, Charts), St. Jude Medical (down $0.21 to $42.33, Charts) and Biomet (up $0.29 to $42.40, Charts).

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