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" ... At this point, there have been no confirmed externalizations of Durata leads due to inside out abrasion from any source. At the summit, one case of Durata externalization was presented, but St. Jude and independent engineering analysis supported a mechanism of outside-in abrasion due to a tricuspid valve ring. ... "
" ... • Due to significant limitations of the studies, we are still lacking a true measure of the incidence of these leads’ failures and externalizations. The MAUDE database relies on voluntary reporting and therefore has both numerator and denominator problems. Fluoroscopic externalization evaluations are just now getting started and we will need to see more studies before the story is clear. ... "