Letters Section Editor: Robert M. Golub, MD, Senior Editor.
To the Editor: In his Commentary on the implications of recent implantable cardioverter defibrillator malfunctions for safety issues involving medical devices,1 Dr Maisel inferred that St Jude Medical's method of estimating failure rates was flawed and would underestimate the true incidence of device failures. He based this statement on an editorial comment2 referencing the device manufacturer's field advisory in 2000 on Trilogy pacemakers.
Levine PA, Kohanyi G. Malfunctions of Implantable Cardioverter Defibrillators. JAMA. 2006;295(2):161-162. doi:10.1001/jama.295.2.161-a