UPDATE: Medtronic Concerto heart device approval re-affirmed by FDA

On January 31, 2007 we posted information regarding allegations of problems with the Medtronic Concerto heart device.  A former employee indicated that Medtronic ignored signs of instability in the wireless monitoring capabilities of the device, failing to test or correct problems before allowing the product to be implanted in 11,000 patients.  On February 1, 2007, the Wall Street Journal reported that the FDA Concerto investigation of the allegations found nothing that would have altered their decision to approve the device.  Medtronic also stated that they have no reports of adverse events associated with the wireless features. 

Any further updates will be posted, and if we learn of any further reports of Medtronic Concerto problems the information will be found in the Defective Products News and Alerts section of our website.