May 14th, 2013
The majority of patients who receive an ICD for primary prevention without a pacing indication have a dual-chamber ICD implanted. Although there are a number of theoretical advantages with dual-chamber devices, they are more likely to cause complications than single-chamber devices. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines […]
March 28th, 2013
A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead. St. Jude’s ICD lead troubles date back to early case reports involving the Riata and Riata ST leads that ultimately led […]
January 28th, 2013
The researcher and EP who first documented problems with St. Jude next generation leads reacts to the FDA’s recent letter to the company and explains what he is doing for patients who have received these devices.
January 16th, 2013
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges […]
May 10th, 2012
The Heart Rhythm Society meeting kicked off in Boston this morning. Edward Schloss recounts the important opening session in which FDA-recalled St. Jude ICD leads Riata, Riata ST, and Durata were discussed.
March 7th, 2012
In recent years, defects in ICD leads have caused recalls and provoked broad concerns among healthcare professionals and patients alike about the safety and reliability of ICDs and other implanted cardiac devices. Now a key player in these events proposes that a computer software program can better monitor ICD leads and provide earlier warnings of […]
February 16th, 2012
Let’s enforce a robust, active postmarket surveillance system that will allow doctors in the field to draw their own conclusions about the safety of devices based on much better data without hampering innovation.
September 12th, 2011
Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that […]
January 31st, 2011
Women, younger patients, those with hypertrophic cardiomyopathy, and those with arrhythmogenic right ventricular dysplasia or channelopathies may be more likely to develop Sprint Fidelis lead failure. Robert Hauser and colleagues at the Minneapolis Heart Institute, the Mayo Clinic, and Beth Israel Deaconess Medical Center analyzed data from 1023 patients who received Fidelis leads and 1668 […]