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An adverse event reported by one doctor in connection with a St. Jude Durata defibrillator lead appears to be disturbingly similar to problems with St. Jude Riata leads, which were recalled last year amid reports that the small wires that connect a defibrillator to the heart may fail.
The FDA received a MAUDE Adverse Event Report submitted last month by a physician who indicates that a patient had to have leads from a St. Jude Durata implantable cardioverter-defibrillator (ICD) removed because the conductors were poking through the insulation.
This is nearly identical to the issues that led to a St. Jude Riata and Riata ST ICD recall, which came in the form of a Physician Advisory Letter sent by St. Jude in late November 2011, indicating that patient deaths and serious injuries ahd been linked to the externalized conductor problem.
The internal defibrillators are designed to be implanted near a patient’s heart, monitor the heart rhythms and give life-saving electrical shocks if necessary. The defibrillator leads, which deliver the electrical charge, are supposed to remain covered by insulation once implanted.
If the leads penetrate the insulation, leaving parts of those wires bare and uncovered inside the patients’ bodies, it may result in unnecessary shocks or could cause the defibrillator to fail to deliver a life-saving charge to the heart when it is necessary.
The recalled St. Jude Riata leads have posed a serious health concern, as it is largely impractical for patients to have the ICD leads removed, leaving patients with more frequent medical follow ups and the need to hope that they do not experience any of the problems associated with the small wires that connect their implanted defibrillator to their heart.
According to the recent MAUDE Adverse Event Report, problems were discovered with a St. Jude Durata lead on April 18, 2012, when non-invasive programmed stimulation of the ICD “revealed undersensing of ventricular fibrillation after induction.”
“Fluoroscopy of lead revealed externalization of conductors,” according to the report. “The externalization was confirmed at lead extraction.”
The report does not identify the doctor nor the hospital involved in the treatment. Although this appears to be the only report involving problems with Durata leads, following news of the report, St. Jude Medical shares dropped 6%.
Earlier this year, a study presented at the American College of Cardiology Meeting in Chicago raised concerns about the problems associated with the Riata leads, after researchers examined reports contained in the MAUDE database, and found that two-thirds of the leads suffered from more than one problem. In addition, researchers linked 22 deaths to the St. Jude Riata leads.
Following that study, St. Jude criticized the findings, suggesting that use of the MAUDE data is an inaccurate way to evaluate problems, indicating that the data often contains incomplete reports that do not fully reflect the conclusions following testing and review of the reported malfunction.