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Cosmic radiation and ICDs

This article was originally published in The Gray Sheet

Executive Summary

St. Jude Medical discovers that background levels of atmospheric ionizing cosmic radiation can affect the RAM chip in some of its older implantable cardioverter defibrillator models, including the Photon DR,Photon Micro VR/DR andAtlas VR/DR. No adverse events have been linked to the problem. The estimated incidence of the anomaly in the affected devices is 0.00257 over the five-year projected life of the device. "Although the incidence rate is low, and there have been no serious patient injuries or deaths reported to St. Jude Medical attributable to this anomaly, the company is taking a conservative approach in advising the medical community and regulatory agencies," the company announced Oct. 7...

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