NEJM Reviews Guidant Defibrillator Malfunction Report
MedSun: Newsletter #5, June 2006
The New England Journal of Medicine (NEJM) on June 1, 2006, published the observations of several members of the independent panel created by Guidant Corporation to examine the company’s actions regarding the potentially fatal malfunctions of its implantable defibrillators. Panel members were asked to conduct an unbiased examination of the methods used to identify malfunctions and evaluate products in the postmarketing phase, and of policies regarding communication within Guidant and with physicians and patients. Recommendations for corrective actions were also requested.
Guidant has made the panel’s report available to the public, and the results of a concurrent study by a task force convened by the Heart Rhythm Society are available as well.
Links to both of these documents, and the complete text of the article referenced above, can be found at