St. Jude Medical has asked the Heart Rhythm Journal to retract a study published last month that linked its Riata line of internal defibrillator leads to more 20 deaths. In a statement issued by St. Jude, the company asserted the Riata lead study was biased and based on inaccurate facts.
According to the Heart Rhythm Journal the purpose of the study in question was to assess the deaths of Riata and Riata ST patients that had been reported to the FDA in order to determine if they were due to lead malfunction.
Cardiologist Robert Hauser wrote in the article that “high-voltage failures” of the Riata leads had caused 22 deaths. The high voltage failures were not the result of protruding wires, Hauser said, but rather cases where the silicone coating of the Riata defibrillator lead wore away. Hauser asserted that deaths caused by the alleged Riata malfunctions were about nine times greater than those associated with the Quattro Secure, a rival lead made by Medtronic Inc. Hauser’s assessment was based on a search of the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database. None of the deaths seen in the study were attributed to the protruding wire issue that prompted last year’s Riata recall.
According to a report in The New York Times, St. Jude is not disputing Hauser’s finding that at least 20 Riata lead patients have died in such episodes. Rather, the company insists that Riata is not alone in being associated with this type of problem. The company further claims that Hauser undercounted the number of deaths associated with Medtronic’s Quatro Secure lead.
According to Bloomberg, Hauser has now said the safety reports, and therefore his study, aren’t comprehensive and probably don’t represent the full number of incidents stemming from both devices.