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St. Jude Served with FDA Warning Letter

Apr 23, 2009 | Parker Waichman LLP

The U.S. Food and Drug Administration (FDA) sent a warning letter this week to St. Jude Medical Inc. because of faulty manufacturing practices at its catheter manufacturing plant in Minnetonka, Minnesota. The letter was released in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), said BizJournal.

The filing stated that the FDA inspected St. Jude Medical’s Atrial Fibrillation (AF) Division’s catheter facility on a number of occasions from December 8 and December 19 and notified St. Jude Medical on December 19 that it observed issues with the manufacture and assembly of its Safire ablation catheter, reported BizJournal, which fix irregular heartbeats and destroy damaged and diseased tissue with heat, explained the Associated Press (AP). The warning letter was issued last Friday, said the AP.

The FDA said it would not approve new devices for manufacture at the St. Jude Medical plant until the firm corrects the outstanding problems, said the AP, noting that faulty record keeping was among the problems cited.

Typically, catheter systems consist of an energy generator and an attachable catheter, which is used on the patient's tissue, said the AP.

This is not the first time St. Jude Medical has been the subject of controversy over its products. The St. Jude Symmetry Bypass Aortic Connector has been associated with a high occurrence of heart attacks, respiratory failure, and has been linked to several deaths, with adverse effects that include graft narrowing, valve leakage, failed deployment, and occlusion. The St. Jude Symmetry is commonly used in "beating heart" or "off machine" heart bypass surgery, which has gained in popularity because it eliminates the need for the patient to be connected to a lung machine during bypass surgery and enables thoracic surgeons to attach saphenous (leg) vein grafts to the aorta without sutures and without clamping the aorta during the procedure.

The St. Jude Medical Symmetry device was approved in 2001 after an abbreviated approval process; thousands of the devices have since been implanted in patients. Despite adverse reports, St. Jude Medical neither conducted clinical trials or testing of a larger segment of the post-cardiac bypass population, nor has it made any alterations in design or manufacture to lessen the great danger the connector poses to patients.

Also, St. Jude Medical said it identified a memory chip problem in some of its older implantable cardioverter defibrillators (ICDs) devices, which stems from a memory chip St. Jude Medical used through 2002 that is susceptible to background radiation. St. Jude Medical notified doctors and federal regulators of a software problem in some models of its ICDs that could cause the heart-shocking device to malfunction. About 39,000 patients are affected by this news.

ICDs are implanted devices the size of a stopwatch that are placed in the upper chest and shock or pace an irregular heart beat back into rhythm. In ICDs past their mid-life, a series of shocks might be skipped as the device delivers its routine of multiple shocks to revitalize the heart. The first shock would be delivered, but the device might deliver fewer than the maximum of six shocks per episode. A second problem could cause a temporary increase in the device's pacing rate. In addition to its shocking therapy, some patients need an ICD that can pace their heart, as well.

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