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January 11, 2006

Malfunctions of Implantable Cardioverter Defibrillators—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;295(2):161-162. doi:10.1001/jama.295.2.161-b

In Reply: Dr Levine and Mr Kohanyi state that with regard to the St Jude Medical Trilogy pacemaker advisory, “the failure rate based on our analysis of returned devices was not underestimated.” As stated in the Commentary, it is often difficult to estimate the true incidence of an observed malfunction. The data from Levine's own editorial1 regarding the St Jude Medical Trilogy pacemaker advisory were accurately cited in the Commentary as an example of this difficulty.