St. Jude Defibrillator Lead Factory Problems Resolved, Per FDA
St. Jude Medical reports that the FDA has given the all-clear for operations at its Sylmar, California manufacturing facility, which makes the Durata defibrillator leads, about 18 months after the agency cited the facility for quality control problems.
In a press release issued on July 2, the medical device manufacturer states that it has been notified by the FDA that the company has successfully addressed all of the agency’s concerns, which led to a freeze on the approval of certain medical devices about 18 months ago.
In January 2013, the FDA sent a warning letter to St. Jude Medical announcing that it was halting the approval of class III medical devices from the facility until systemic quality control problems could be fixed. The freeze came after inspections turned up what the agency determined were too many problems.
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Class III medical devices are those that are generally classified as the most likely to harm a patient if something goes wrong, as well as devices for which the safety profile has not yet been established.
The original FDA investigation report, which was released by the agency in November 2012, outlined a number of concerns over manufacturing deficiencies where the St. Jude Durata defibrillator leads are made.
The inspection report found that St. Jude failed to adequately test design changes made to the Durata leads following a recall of its Riata defibrillator leads.
Among the 11 different deficiencies cited in the inspection, investigators found problems with design verification and validation, how the company responded to complaints, and noted that lead design elements were tested only once, even though the company’s own protocols called for five tests.
St. Jude Riata Lead Problems
The inspection came in the wake of a St. Jude Riata and Riata ST defibrillator lead recall, where the small wires used to connect implantable cardiac defibrillators were poking through the insulation materials, resulting in exposed wires inside some patients.
This may lead to unnecessary shocks or cause the ICD to fail to deliver a life-saving jolt when needed. As a result of the problems, a number of patients have had to undergo risky surgery to remove and replace the lead wires.
The Riata leads were once made at the Sylmar facility.
Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that more than 70,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.
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.
Several hundred patients who received the recalled wires are now pursuing lawsuits over the St. Judge Riata leads, alleging that the manufacturer sold a defective and dangerous medical device and failed to disclose the risk of early failure.
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