NEW YORK —
The component at issue — an electrical wire, or lead, called the Durata — connects an implanted defibrillator to a patient’s heart. In the letter, dated Jan. 10, the agency said that St. Jude had failed to address a variety of concerns about the component arising from an FDA inspection last fall of a company factory in California.
In a filing earlier this week with the Securities and Exchange Commission, St. Jude disclosed the receipt of the FDA warning letter. In that filing, the company said the agency had notified St. Jude that it would not, among other things, approve applications for complex medical devices until the problems found during the inspection were addressed.
St. Jude stated in the filing that the company was ‘‘giving the highest priority to fully remediating these concerns.’’
The actual letter suggested that the FDA’s patience with St. Jude was running out.
Medical specialists have raised concerns about the insulation used to seal the Durata’s electrical wires. St. Jude insists it is safe and is performing well. About 350,000 patients have been implanted with the Durata and the Riata ST Optim, another St. Jude lead that uses a similar insulation, according to the company.
In the letter, the agency also said it had determined that the Durata was ‘‘misbranded.’’ Specifically, the agency said St. Jude had not made required reports in a timely fashion about possible malfunctions of the Durata lead that may have resulted in deaths or serious injuries.
A St. Jude spokeswoman, Amy Jo Meyer, said that the complaint reports at issue involved defibrillator wires that had not been implanted in patients. She added that the company was taking steps to address the FDA’s concerns and that St. Jude would continue to ship products from the California plant that was the subject of the inspection.