Davidsson GA, et al. - Researchers distinguished all 52 individuals who had the recalled lead implanted between November 2002 and October 2009 in Iceland, along with 50 individuals who had implantable cardioverter/defibrillators (ICDs) from other manufacturers from February 2010 to November 2012 to serve as controls. They ascertained the occurrence of lead failure by externalization of the conductor (EC), described as direct visualization of the conductor wires outside the lead body on fluoroscopy or being visualized on a chest radiograph; electrical dysfunction, high-frequency, low-amplitude irregular signal (electrical noise) between ventricular signals on the intracardiac ICD electrogram; and lead fracture. Additionally, inappropriate shocks and deaths were compared. No significant differences were found with respect to demographic and device characteristics between the groups. Seven individuals (13.5%) had electrical dysfunction, 2 (3.8%) had EC, 7 (13.5%) had both, and 3 (5.7%) had lead fractures across the full study period in the recalled lead group. Hence, in total, 19 individuals (36.5%) had lead failure, involving 1 individual in whom therapy for ventricular tachycardia was not delivered, resulting in death. It was concluded that the development of more durable ICD leads with regards to biomaterials and engineering design is warranted.