I called Dave Steinhaus, MD, Vice President and Medical Director of the Cardiac Rhythm Management Division at Medtronic yesterday regarding the Concerto allegation and he returned my call about 45 minutes ago. In summary, it seems there were a number of engineering concerns that their former engineer, Christopher Fuller, had regarding the wireless platform that Medtronic implemented for the Concerto device (and also pertains to their Virtuoso ICD). Some of these concerns were addressed, he said, but others were not felt to be of concern to whom he raised issue with at Medtronic. He confirmed that Mr. Fuller then chose to report his concerns to the FDA and a Minnesota senator. Dr. Steinhaus referred me to this news release from Reuters, claiming the FDA investigation is closed.
In essence, their stand at present is that this is a disgruntled employee, and that there has been no failures or complaints of any of their Concerto or Virtuoso implants to date, and they stand by its safety.
Addendum: 1 Feb 2007 1845PM - Regarding the above claim from the Reuters press release that states: "Medtronic said it has had no reports of patient safety issues related to the wireless features of the device." I have checked and found one patient injury reported on the FDA Maude database from the Concerto device dated August 1, 2006 resulting in a patient injury. It can be viewed here. I was unable to see if other reports occurred in 2007. In no way should be construed as being related to Mr. Fuller's allegations, nor related to significant engineering issues with the device.
This one device malfunction in an estimated 11,000 implants is well below the prior reported average of 20.7 device malfunctions in 1000 implants noted by the prior report of the Heart Rhythm Society's Task Force of Device Performance Policies and Guidelines. - Wes