Following the recall event in 2005, the Guidant Corporation commissioned an independent panel charged with studying, analyzing, and evaluating the policies and procedure of the cardiac rhythm management business with regard to postmarket device surveillance. This report summarizes the findings and recommendations of the panel.
Cardiac rhythm management is care given to patients that have or may be at risk for arrhythmias including those who have been resuscitated from cardiac arrest, have irregular, premature, or rapid heartbeats, or experience unexplained Fainting episodes.
Patients also include individuals who may be at risk of dying suddenly from cardiac arrest, are in need of a pacemaker or automatic defibrillator, or have potential genetic links to heart rhythm problems.
|This document has been retired because it is no longer current.|