The FDA announced that it had concluded an investigation into the safety of Medtronic’s Concerto defibrillator and found no evidence of safety issues. On Tuesday, the Wall Street Journal reported the investigation was taking place after a former Medtronic engineer accused the company of insufficient testing with regard to its high-tech device.
The Concerto CRT-D device was approved by the FDA in May of last year. The device uses what’s called “wireless telemetry†technology, which allows physicians to remotely monitor a patient’s vital signs, as well as data about the defibrillator’s performance. A former Medtronic engineer, Christopher Fuller, was concerned about the stability of the high-frequency signal that the device uses to communicate this information and he alerted the FDA to the potential safety concerns. (He resigned from Medtronic in December of 2005, largely because of these concerns.)
FDA spokeswoman Heidi Rebello told the St. Paul Pioneer Press, “This investigation included a scientific review of the allegations, an inspection of the manufacturing facility, a review of the data previously evaluated in support of the marketing application, and a review of available adverse event data. To date, FDA has found nothing that would have influenced its decision to approve this device.†She added that the agency took the former employee’s allegations “very seriously.â€Â
The Minneapolis-based company says that approximately 11,000 of these devices have been implanted in heart patients since it was approved by the FDA with a price tag of $30,000 or more per device. Medtronic is expected to post more than $12 billion in total revenue for 2007.
