Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead

Risk Stratification and Role of Implantable Defibrillators for Prevention of Sudden Death in Patients With Hypertrophic Cardiomyopathy

“…The highest rate of complications is in younger HCM patients, largely because their activity level and body growth places a continual strain on the leads, which are regarded as the weakest link in the system. 63, 69 Extended lead survival is par- Figure 10. Primary prevention decision tree.…”

“…69 The implant procedure has been largely free of significant risk, without reported deaths, although selected patients with extreme hypertrophy, or who have been administered amiodarone, may require high-energy output generators or epicardial leads. 10, 13 ICDs Worldwide: Cultural and Other Factors…”

Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

“…This lead family has been in distribution since 2004. The first signals of elevated risk of fracture emerged in July 2007 when Hauser et al [1] published their study results. In October 2007 Medtronic Inc. issued Urgent Medical Device Information [2] to all physicians and hospitals who were using SF leads stating that "no more SF leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company".…”

“…The decision to publish experiences with SF leads has been undertaken for the following three reasons: (1) to provide information about failure rate of 6948 and 6949 SF leads in a single center, (2) redefine and assess the importance of risks factors according to a population implanted in the studied hospital, and (3) make findings available for informed management of patients with malfunctioning leads.…”

Fluoroscopic investigation of Riata® transvenous defibrillator leads

“…Since the introduction of implantable cardioverter-defibrillator (ICD) for sudden cardiac death prevention, there have been a number of reported malfunctions related to lead durability or performance [1]. Lead material and design play a crucial role in optimal performance of an ICD system and over the years, there have been several attempts to make thinner leads offering easier and better implantation profiles.…”