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Medtronic issues safety alert for certain atrial pacing leads due to possible insulation problem.

This article was originally published in The Gray Sheet

Executive Summary

MEDTRONIC RECOMMENDING MONITORING OF CERTAIN CAPSURE ATRIAL PACING LEADS according to Medicare guidelines in an Oct. 4 safety alert issued to physicians worldwide, the company says. In tracking the performance of three models of Capsure leads, Medtronic found that some of the devices were experiencing intermittent over- and undersensing and possible intermittent loss of capture. No injuries or deaths have been attributed to the problem.
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