Minneapolis / St. Paul Business Journal by Mark Reilly, Managing Editor
Doctors had told St. Jude Medical Inc. about problems with the medical device maker's Riata leads for years before the Little Canada company finally recalled the device.
The Wall Street Journal has a report on the complaints, which St. Jude responded to by saying they were isolated incidents. But documents reviewed by the paper show that the company was tracking reported problems with the Riata as early as 2005, before reporting problems to doctors in 2010. The leads connect implantable defibrillators to the heart.
The Riata problems later caused tension between St. Jude and Medtronic; St. Jude accused its Fridley-based competitor of conducting a "whisper campaign" against its Durata product (which replaced the Riata). Medtronic denied the allegation. It also called on Heart Rhythm Journal to retract research published by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation, who argued that St. Jude's Riata defibrillator leads were prone to failure.
St. Jude hasn't been accused of any wrongdoing, but experts say the matter shows an industry-wide problem of monitoring devices after they're released.