In a news release, St. Jude noted how the FDA states on its website that the database, known as MAUDE, is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”
The journal study cited how the MAUDE database was searched in February 2012 for deaths associated with the Riata and Ratia ST products as well as Quattro Secure leads (the wires that connect a defibrillator to a patient's heart) manufactured by Minneapolis-based Medtronic.
The researchers wrote that they found 133 deaths with 22 caused by Riata or Riata ST lead failure and five caused by Quattro Secure failure. They added that “Riata and Riata ST deaths were typically caused by short-circuits between high voltage components.”
“That is the conclusion of our study and we stick by it,” said the report's lead author, Dr. Robert Hauser, a researcher with the Minneapolis Heart Institute Foundation and a cardiologist with the Minneapolis Heart Institute at Abbott Northwestern Hospital.
Medtronic's handling of MAUDE reports was also criticized in the release and it was added that the use of MAUDE data creates a bias against other companies that “more transparently report on device malfunction.”
“There is a range of detail available in MAUDE reports, with Medtronic generally reporting the least amount of detail compared with other companies in the industry,” St. Jude said in the release. “In addition, the detail and rate of reporting has increased since Medtronic's Cardiac Rhythm Management business received a warning letter from the Food and Drug Administration in 2009, meaning events prior to this date in the analysis may have been under-detected.”
A spokeswoman for the Heart Rhythm Society said they had no comment at this time. Medtronic downplayed the St. Jude demands.
“We are aware of St. Jude's press release and are looking into the facts,” said Christopher Garland, Medtronic vice president of communications, in an e-mail. “This appears to be nothing more than a difference of opinion between St. Jude Medical and Dr. Hauser.”