FDA Finds No Fault with Medtronic Heart Device

The FDA said it has 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, according to CNN.

The agency had investigated the device after questions were raised by a former Medtronic employee about the device manufactured by the Fridley, MN-based medical device company, according to the Pioneer Press.

The questions, first reported in Tuesday’s Wall Street Journal, focus on the wireless telemetry capabilities of Medtronic’s Concerto CRT-D device, which was approved by FDA in May 2006.

Wireless telemetry allows for communication between implanted heart devices and the devices used by doctors to program the implants.

The wireless capability is meant to speed patient check-ups, during which doctors review data retrieved from the implant. The technology also is meant to allow for speedier implant surgeries, since programming devices don’t have to be brought into the sterile field of the operating room.

According to the Wall Street Journal report, the FDA’s Minneapolis office investigated concerns raised by former employee Christopher Fuller, who told the agency that Medtronic failed to do enough testing on the wireless capability. The lack of testing raises potential safety problems, the newspaper reported.

Medtronic spokesman Rob Clark said the company thoroughly investigated Fuller’s concerns and either addressed them or concluded the allegations were without merit.

Fuller’s concerns were discussed with FDA as part of a routine inspection of Medtronic facilities that was completed in July 2006, Clark said.