St. Jude Claims Durata Lead Failure Unrelated to Riata Problems

Officials from St. Jude Medical claim that the recently reported problems with a Durata defibrillator lead were different from those that led to a St. Jude Riata defibrillator lead recall last November, where the small wires were found to be prone to poke through the insulation. 

Last month, an adverse event report submitted to the FDA indicated that leads from a St. Jude Durata implantable cardioverter-defibrillator (ICD) had to be removed from a patient’s body because the conductors were found poking through the insulation.

Because the St. Jude Durata lead failure sounded just like the problems previously reported with the St. Jude Riata lead, which was linked to hundreds of reported injuries and dozens of deaths, the news caused concerns among investors, consumers and the medical community.

In response to the report, St. Jude now indicates that while the Riata leads were recalled because the silicone surrounding the conductors deteriorated faster than expected, it appears that the Durata leads in the reported incident were damaged because they scraped against a hard, calcified heart valve inside that patient’s body or against another lead.

Internal defibrillators are designed to be implanted near a patient’s heart, monitor the heart rhythms and give life-saving electrical shocks when and if necessary. The defibrillator leads connect the device to the heart, and deliver the electrical charge necessary to return the heart to normal rhythm. However, the small wires are supposed to remain covered by insulation.

A St. Jude Riata and Riata ST ICD recall was issued in late November in the form of a Physician Advisory Letter, after a number of patient deaths and serious injuries were linked to the externalized conductor problem. The insulation on the Riata leads allowed the conductors to become exposed, which could cause unnecessary shocks or result in a failure to deliver life-saving shocks when required.

Earlier this year, a study presented at the American College of Cardiology Meeting in Chicago raised concerns about the problems associated with the Riata leads, after researchers examined reports contained in the MAUDE database, and found that two-thirds of the leads suffered from more than one problem. In addition, researchers linked 22 deaths to the St. Jude Riata leads.

Following that study, St. Jude criticized the findings, suggesting that use of the MAUDE data is an inaccurate way to evaluate problems, indicating that the data often contains incomplete reports that do not fully reflect the conclusions following testing and review of the reported malfunction.

The data on the failure of the St. Jude Durata lead was found in a single adverse event report submitted through the FDA MAUDE system.