Guidant letter about risks never sent
September 3, 2006 11:02

In June 2006, new unsealed court documents show that Guidant Corp. drafted a letter warning doctors of a dangerous electrical malfunction in some of its defibrillators designed to restore a normal heartbeat, however, the letter was never sent. Instead, a toned... (Read this Article)

The FDA frequently issues safety advisories for automated external defibrillators (AEDs) or portable electronic device used to restore regular heart beat in patients with cardiac arrest. Successful resuscitation of persons with cardiac arrest depends on prompt... (Read this Article)

What is a heart defibrillator?

An implantable cardioverter-defibrillator (ICD) is a device that is implanted under the skin of patients that are at risk of sudden cardiac death. The defibrillator was designed primarily to deal with ventricular fibrillation or coordination of the heart muscle to pump blood. The process of implanting an ICD is similar to that of a pacemaker. ICDs constantly monitor the rate and rhythm of the heart and are programmed to deliver an electrical shock when the ventricles of the heart go faster than the set rate.

Imagine having an implanted pacemaker or defibrillator. Imagine thinking that these lifesaving devices are going to save your life. If only it was that simple. Hundreds of thousands of Guidant implanted pacemakers and defibrillators are being recalled which means that hundreds of thousands of patients have to go to the hospital to have the Guidant heart devices removed and have new heart devices replanted. This sets up patients for anxiety, trauma, infection, expense, death, and cause for alarm as to question the safety of the newly implanted devices.

Within the past 18 months the Food and Drug Administration recall notices have targeted more than 300,000 implantable heart devices, a majority from Guidant Corporation. Problems with devices have ranged from minor flaws to premature battery depletion. In some instances, a malfunction allowed moisture to seep into the device. A recall last year of a Guidant defibrillator has prompted by at least two deaths. )

In July 2006, FDA met with Guidant to discuss the firm's recent announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor. The capacitor controls how the device holds its power supply. The FDA fully supports Guidant's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction.
Guidant's problems may include intermittent or permanent loss of therapy, premature battery depletion, or other malfunctions. The FDA is closely monitoring the situation and met with Guidant to discuss their plans to investigation the problem, inform physicians, and resolve the problem as quickly as possible. (FDA)

In May 2006, a lawsuit was filed in Pennsylvania by Public Citizen on behalf of Emergency Care Research Institute (ECRI), the nation's leading independent medical product testing organization, the right to publish information about Guidant's medical devices.... (Read this Article)