New York, NY - A former Medtronic engineer says he resigned from the company over "serious issues" regarding Medtronic's evaluation of its Concerto cardiac resynchronization therapy/defibrillator, prior to obtaining FDA approval, the Wall Street Journal reports [1]. Christopher Fuller worked for the company until late 2005 but has since quit and approached the FDA with claims that the company didn't adequately test the Concerto.

The FDA approved the Concerto for sale in the US in May 2006—the device can cost upwards of US $30 000.

"At issue is the wireless technology by which doctors and nurses can remotely monitor how well the device is working and how a patient is doing," Thomas M Burton writes in the paper's January 30, 2007 issue. "Mr Fuller contends that Medtronic didn't do enough to test this wireless capability, and that there are, as a result, possible safety problems with the Concerto device."

Medtronic has responded, saying that it believes the device to be safe and that 11 000 devices have been implanted in the US. "The company said it has investigated Mr Fuller's concerns 'thoroughly' and has either addressed his concerns or 'believes them to be without merit,' " Burton quotes the company in his story.

Fuller has suggested that the Concerto's long-distance telemetry is subject to instability and that this instability can cause excessive battery depletion, "burn up" other circuitry in the device, or prevent it from working properly.

But Medtronic spokesman Rob Clark told Burton that the company "believes the frequency band used by doctors to monitor patients with the Concerto 'is dedicated for these uses, and we believe it's extremely stable. We have had no adverse events reported due to the wireless telemetry features of the devices.' "

The FDA is investigating.