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" ... St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time. ... "
" ... The Nashville investigators performed fluoroscopic and electrical evaluation of 87 patients with Riata (n=74) or Riata ST (n=13) leads. Patient selection was due to lead failure, need for lead extraction, proximity to device battery replacement, or patient request after counseling. They found a high incidence of fluoroscopic abnormalities (externalization or abnormal cable spacing) in both families of leads, and modeling techniques clearly demonstrated that externalization increased over time. ... "
" ... The attendees were polled again at the completion of the session and already high concerns were amplified. A higher proportion than earlier (58%) of those polled felt the Riata situation was a more serious problem than the Fidelis recall and 44% indicated that they had enough concern about the market released Durata lead that they would not be using this in the future. Despite HRS consensus recommendations to the contrary, 55% of attendees favored routine repeated fluoroscopic monitoring. ... "