The FDA on January 30, 2007 announced that the agency started an investigation that is looking into accusations by a former Medtronic Inc. engineer that the medical-device company didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The local office of the FDA in Minneapolis is conducting an investigation into the claims by Christopher Fuller, who worked until late 2005 at Medtronic as an engineer.
The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient’s life if the heart goes into cardiac arrest. The wireless technology by which doctors and nurses can remotely monitor how well the device is working and how a patient is doing is the main 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 said that approximately 11,000 of the devices have been implanted in the United States and that it believes the device to be safe. The company said it has investigated Mr. Fuller’s concerns “thoroughly” and has either addressed his concerns or “believes them to be without merit.” The device went on the market last June after being approved for sale by the FDA in May.
Mr. Fuller, an engineer who had worked on the Concerto device, said he resigned from Medtronic in protest over what he terms “serious issues” regarding “how Medtronic evaluated the Concerto.” In 2006 Mr. Fuller contacted the FDA and the offices of the U.S. senators from Minnesota. In one letter to Republican Sen. Norm Coleman, Mr. Fuller wrote that the Concerto device’s long-distance telemetry “exhibited instabilities in testing” and that Medtronic “has chosen to ignore the problem.
Medtronic spokesman Rob Clark said 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.” Mr. Fuller contends that this instability can “prevent other circuits from behaving properly” and can lead to battery depletion or can “burn up” other circuitry in the devices.
Legal Help For Victims Affected By Medtronic Concerto
If you or a loved one have been implanted with a Medtronic Concerto device and you suffered a serious injury or death, please fill out the form at the right for a free case review by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).