Recently an anonymous doctor voluntarily reported the dangerous defect of an externalized lead wire in a St. Jude Medical, Inc.’s (“SJM”) Durata defibrillator to the U.S. Food and Drug Administration (“FDA”). Interestingly, the doctor did not first report this issue to SJM itself.
As our office has discussed in numerous prior blogs, SJM ceased Riata wire sales in December, 2010, and ultimately recalled the product one year later in response to mounting reports that the insulation coating the metal lead wires could deteriorate and cause the defibrillator to malfunction. It goes without saying that, if such a result was to occur, the patient’s life could be in jeopardy. Accordingly, SJM replaced the Riata product with its new line of leads—Durata. However, SJM is now faced with the first report alleging a failure—or externalization—of a Durata lead.
In response, an SJM spokesman said in a statement that “[t]he report indicates that it was filed by a physician, but does not provide the device serial number, the name of the physician or institution, which would enable us to learn more about the circumstances . . . . We will make every effort to learn more about this report as quickly as possible.”
As one analyst commented, “[t]his new report raises questions on whether Durata is truly immune to the same failures that plague Riata and at the very least, will keep up the discussion on whether St. Jude’s smaller diameter leads should be used when other more reliable leads are available.”