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Background: The Medtronic Sprint Fidelis (SF) implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a higher than expected failure rate. Because of patient safety, Medtronic announced two advisories consisting of (1) adjustments in device settings (October 2007) and (2) installation of a lead integrity algorithm (May 2008). The objective of this study was to evaluate the effect of Medtronic's announcements on patient safety....