The Riata ICD lead recall: Two perspectives

February 16, 2012 by MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

Robert Hauser, MD published a perspective piece in the New England Journal of Medicine today entitled "Here We Go Again — Another Failure of Postmarketing Device Surveillance." In the piece, he offers these suggestions on how to detect these failures earlier:

Opportunities have emerged for automated tools to prospectively monitor multicenter device databases for early, low-frequency adverse events and to compare suspect devices with established products that have been shown to be reliable.(4) The goal is a postmarketing surveillance system that not only detects device problems early but also accumulates the data needed to guide patient care. Until such a system exists, St. Jude Medical should initiate a study with these attributes for recalled Riata and Riata ST leads and for the currently marketed Durata leads. Indeed, all manufacturers should conduct postmarketing studies of this type for marketed class III devices that sustain or support life.

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