St. Jude Durata Defibrillator Leads Under FDA Scrutiny

The attorneys at Morgan & Morgan investigated potential lawsuits on behalf of patients who have been implanted with a defibrillator lead, known as Durata, manufactured by St. Jude Medical.

Allegations surfaced that quality control and design problems may have put patients at risk for serious injury or death. In late 2012, the FDA inspected a St. Jude manufacturing facility in California and found nearly a dozen problems related to the design and manufacture of the Durata lead. St. Jude has failed to properly address many of these concerns, prompting a strongly worded letter from the FDA which warns of additional action if the issues related to the defibrillator lead are not resolved.

St. Jude Durata Lead and Inspection Problems

In Oct. 2012, an FDA inspection of St. Jude’s manufacturing plant in Sylmar, California uncovered 11 problems related to the Durata lead, many of which stemmed from deviations from standard manufacturing processes. According to the FDA, St. Jude’s response to five of these issues, including the company’s failure to establish and maintain adequate procedures for verifying the device design, was inadequate. In this specific violation, the FDA found that the company tested each lead only once, even though internal process required the components to be tested five times.

Durata Leads Under Scrutiny for Failure

The Durata lead has faced increasing scrutiny over the past several months, culminating in a warning letter from the FDA. Some have expressed concern that failures in the Durata leads are similar to those noted with the older Riata leads. Also manufactured by St. Jude, the Riata leads were subject to a Class 1 recall, indicating that there is “reasonable probability” that the products will cause “serious adverse health consequences or death.” According to reports, wires inside the Riata leads could penetrate the insulation, resulting in unnecessary shocks, or, in some instances, failure to deliver life-saving therapy to restore the heart to proper rhythm.

Injured by a Medical Device?

We are no longer taking Durata cases. To see our active lawsuits, visit our class action page. If you or a loved one has been implanted with a dangerous medical device, you may have legal recourse to collect compensation for medical bills and other damages. To stay up to date on the latest news about medical devices, visit classaction.com.