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St. Jude Riata Lead Wire Patients Face Big Medical Bills | cialis online

St. Jude Riata Lead Wire Patients Face Big Medical Bills

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Faulty St. Jude Riata lead wire patients are facing large medical bills over the recalled heart device manufactured by St. Jude Medical Inc.

According to The Wall Street Journal, although St. Jude Medical covers some of the costs of device replacement, and insurers and Medicare do cover some of the costs of replacement surgeries, patients are responsible for co-payments, travel expenses, and other costs, which could total in the thousands of dollars. Meanwhile, more and more, surgeons are removing the defective leads, even if they do work—a costly and dangerous procedure.

The Riata leads are cables that connect the heart to implantable defibrillators that shock irregular heart rhythms back to normal, explained the Journal. Worse, NewsInferno noted, these defects could fail to release needed life-saving electrical impulses to the heart. Recalled in December, the faulty devices failed in one in five patients, breaking through insulation and leading to dangerous electrical problems.

St. Jude, for its part, has repaid patients for many of the expenses associated with the revision surgeries beyond the warranty; however, the process is informal and not all surgeons are aware of it. St. Jude medical told The Journal that it does not advertise this process and did not discuss patient reimbursement. A number of doctors were unaware of the device maker’s process, said The Journal.

Riata’s five-year warranty, according to a copy of the warranty policy provided by St. Jude, pay’s $600 and allows for a free replacement with a Durata lead, said The Journal. The Durata is manufactured by St. Jude Medical. Should a different lead manufactured by a different device maker be used, the warranty terms would be void, according to St. Jude Medical spokeswoman, Amy Jo Meyer. St. Jude told The Journal that it reviews patient claims that are not covered by the warranty, providing case-by-case assistance, saying it typically covers reasonable medical costs; however, it did not explain its process nor what it considers “reasonable costs.”

In at least one case, however, when a patient was reimplanted with a different, non-St. Jude Medical device—that patient reached out to St. Jude—reimbursement was issued. But, reimbursement was provided in a very informal process. In this case, the patient sent St. Jude Medical a certified letter asking for help.

Bear in mind, St. Jude’s warranty mandates surgeons use its Durata Lead. And, as NewsInferno recently wrote, a new study conducted by a respected cardiologist, has some worried about St. Jude’s line of Durata defibrillator lead wires. Study lead, Dr. Robert Hauser, said that the new coating used on the Durata lead may not prevent the same types of insulation abrasion problems that led to the Riata and Riata ST lead recalls. In fact, Hauser’s study revealed one death was linked to a Riata ST Optim wire failure; the Riata ST Optim lead insulation is made with the same new coating.

The U.S. Food & Drug Administration (FDA) recently urged the 128,000 defibrillator patients, including those with the Riata leads, undergo imaging monitoring to test for abnormalities with the wire’s insulation, said NewsInferno. The agency also ordered St. Jude to conduct studies into the scope of Riata lead failures, and its Durata-series ICD leads and its QuickSite LV and QuickFlex LV CRT leads, among other measures.

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