WikiLeaks of lead extraction: Do we know the truth about Fidelis and Riata?

摘要

Implanting electrophysiologists and implantable cardioverter-defibrillator (ICD) manufacturers are periodically shaken by device and lead failures, resulting in limited or complete recalls and advisories. These events occur with sometimes predictable periodicity and may be devastating for both the patient and physician communities. Directives from the manufacturers and multiple governing bodies instructing us on how to resolve hardware malfunction or failure are frequently delayed, incomplete, or misleading. In many cases, it takes years to uncover "the unwanted truth." The 2 most recent recalls involving what were then widely popular ICD leads affected hundreds of thousands of patients and their physicians. The leads included the Sprint Fidelis (Medtronic, Minneapolis, MN), the Riata (8-F) and Riata ST (7-F) (St Jude Medical, Sylmar, CA) leads. The Fidelis lead was found to be prone to high- and low-voltage conductor fracture.