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Despite design changes made to certain St. Jude defibrillator leads, a study suggests that the new wires may have the same insulation problems that have plagued older models.
Defibrillator leads are small wires used to connect an implantable cardiac device to the heart. The leads monitor the heart rhythms and provide a life-saving electrical shock if necessary.
In recent years, St. Jude has removed several models of their leads from the market, after discovering that they were prone to fail, with the small wires poking through the insulation. This could result in unnecessary shocks or cause the heart device to fail when it is needed to deliver a corrective charge.
A St. Jude Riata and Riata ST defbrillator lead recall was issued late last year, after the medical device manufacturer stopped selling the leads amid reports of the lead conductors becoming externalized due to the insulation problems.
In April 2012, St. Jude announced that it was also halting sales for the QuickSite and QuickFlex leads, after identifying similar problems with the insulation.
Although St. Jude redesigned the insulating material with a mix of silicone and polyurethane, which the company is calling Optim, a study published this week in the medical journal Europace suggests that the insulation problems may also impact newer products as well, including the St. Jude Riata ST Optim and St. Jude Durata leads.
Insulation Problems with St. Jude Riata ST Optim and Durata Leads
The study was authored by Dr. Robert G. Hauser, a prominent cardiologist who previously published a report highlighting the risk of problems with the recalled St. Jude leads, identifying at least 22 deaths and indicating that the Riata leads were failing in multiple ways.
In this latest report, Dr. Hauser indicates that at least one death can be attributed to insulation problems with the new St. Jude leads. Researchers examined the FDA’s Manufacturers and User Device Experience (MAUDE) database and found at least 52 reports of problems with St. Jude’s Durata and Riata ST Optim leads.
Most of the St. Jude defibrillator lead problems involved abrasions of the insulating material, which left conductors exposed inside the patients’ bodies. The one death involved a case where the the lead wire became externalized with a Riata ST Optim ICD.
Many of adverse event reports involved problems where the new St. Jude leads developed electrical problems after the insulation failed, according to the findings.
Concerns for Individuals with St. Jude Defibrillators
If the leads penetrate the insulation, the wire can become exposed inside the patients’ body, posing several risks for patients. In addition, given the difficulty faced in removing the leads, which are inserted through arteries leading to the heart, patients are left with very few options if they received a defective lead.
Earlier this month, the FDA recommended that any individuals who received a St. Jude Riata or Riata ST lead obtain an x-ray or other imaging exam to check the condition of the leads. The agency also recommended that doctors consider remote monitoring of patients with the recalled leads to quickly catch any electrical problems.
St. Jude was also ordered by the FDA to conduct new clinical studies on other defibrillator leads, including the newer St. Jude Riata ST Optim and St. Jude Durata leads.
In recent months, a number of St. Jude Riata lead lawsuits have been filed by individuals who experienced problems with insulation on their lead. The complaints allege that St. Jude failed to manufacture the leads consistent with the FDA approved processes, which may cause the insulation to wear thinner at certain parts due to friction and brasion.