Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm.
Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or Riata ST lead failure. By contrast, only five deaths were caused by failure of the more widely implanted Quattro Secure lead. The authors reported that the Riata deaths “were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.” As reported previously on CardioBrief, Hauser has played an important role in gathering and disseminating information about ongoing concerns about the Riata leads.
“The deaths are rare, but more frequent than you would expect. It’s another example of our flawed regulatory system,” Hauser told the Wall Street Journal. St. Jude told the Wall Street Journal that Hauser’s article contained several errors. Two deaths were counted twice, reducing the total number of lead-related deaths to 20, according to the company. In addition, St. Jude’s chief medical officer, Mark Carlson, said that some of the deaths were “from well-known causes, including wires that were coiled during surgery and ended up rubbing against the defibrillator.”