Medtronic Concerto

The Medtronic Concerto Model C154DWK is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤35% and a prolonged QRS duration.

In January 2007, the FDA commenced an investigation of accusations by a former Medtronic Inc. engineer that the medical device company failed to adequately test its new Medtronic Concerto cardiac device for patients with congestive heart failure. The investigation was sparked by the accusations of Christopher Fuller, an engineer for Medtronic until late 2005. Mr. Fuller claimed the Medtronic Concerto device's long-distance telemetry "exhibited instabilities in testing" and that Medtronic "has chosen to ignore the problem."

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