St. Jude Durata ICD Lead Problems Outlined in Case Report

A new report outlines a case involving insulation failure with a St. Jude Durata ICD lead, which has increased concerns that the newer generation of implanted defibrillator leads may suffer the same insulation problems that resulted in a recall for St. Jude Riata leads. 

The medical journal Heart Rhythm published the case report on March 25, outlining problems with the St. Jude Durata lead seen by doctors from Cedars Sinai Heart Institute in Los Angeles, California.

St. Jude removed the their Riata and Riata ST leads from the market in 2010, amid reports that the small wires used to connect an ICD to the heart were prone to puncture the insulation and become exposed inside patients’ bodies. As a result, individuals could experience complications that result in unnecessary shocks or the failure of the ICD to deliver a life-saving jolt when needed.

In 2006, St. Jude introduced a new line of leads, known as Riata ST Optim, which featured a redesigned insulating material. After concerns began to arise within the medical community over the original Riata design, the newer leads were renamed the St. Jude Durata in 2008. While St. Jude has strongly denied that the new ICD leads suffer similar problems, concerns have existed about the safety of the device.

The new report highlights a case involving a patient who had a St. Jude Durata ICD lead implanted in January 2008 and began showing signs of problems in July 2010, which were described as “inside-out insulation failure.” As a result of the St. Jude Durata ICD insulation failure, the patient required surgery to extract and replace the lead in January.

Last year it was reported that a similar problem with a St. Jude Durata ICD lead was submitted to the FDA’s MAUDE adverse event database. According to that single adverse event report, doctors discovered the St. Jude Durata problems in April 2012, when non-invasive programmed stimulation of the ICD revealed undersensing. After the lead was extracted, it was confirmed that the lead wire had become externalized, or penetrated the insulating material.

St. Jude claimed that the MAUDE report involved problems different from those that led to the Riata lead, indicating that they believed the lead was damaged because it scraped against a hard, calcified heart valve inside the patient’s body or against another lead. However, the report still caused substantial concerns within the medical community about the safety of the Durata lead.

St. Jude Defibrillator Lead Concerns

A St. Jude Riata lead recall was issued in December 2011, after the manufacturer sent several warning letters to doctors about reports of problems with the insulation.

Although St. Jude stopped distributing the leads in 2010, an estimated 79,000 patients in the United States still have the leads inside them, and experts have recommended leaving them in place until there is evidence that they have failed or malfunctioned.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

The agency also indicated at that time that it was ordering St. Jude to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.

A growing number of St. Jude Riata lead lawsuits have been filed against the manufacturer, including wrongful death claims that allege that the Riata’s defects lead to patient fatalities.