Already in 1970, Mirowski and colleagues worked on the development of the first implantable cardiac defibrillator (ICD). Since then, important progression has been made by increasingly complex pacing and defibrillation functions, higher battery durability, and reduction of both device and shock lead size. A large amount of evidence has shown that ICDs are life-saving and cost-effective, both for primary and secondary prevention of sudden arrhythmic cardiac death. In the last decade, a quest for smaller shock lead design was initiated, but unfortunately increasing dysfunction rates of ICD generators and leads were to be unmasked only a few years later.[
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2] Medtronic’s 6.7 Fr Sprint Fidelis lead was recalled by the FDA in 2007 and St. Jude’s 7.6 Fr Riata and 6.3 Riata ST leads were recalled by the manufacturer, FDA and the Dutch authorities in 2011. By then, the vast amount of approximately 227,000 Riata leads, and 268,000 Sprint Fidelis leads had been distributed worldwide. …
