An “implantable defibrillator” sounds like a great idea. It’s an electronic device that a surgeon implants in your body to help you overcome the problems associated with life-threatening kinds of cardiac arrhythmia (also known as irregular heartbeat). As the heart goes out of rhythm, the defibrillator gives the heart a mild shock to reset the rhythm back to normal.
The problem is, these devices are not always as safe as doctors claim them to be. In fact, the U.S. Food and Drug Administration (FDA) recalled certain brands of implantable defibrillators.
FDA recalls certain implantable defibrillators
In 2005, the FDA recalled the following defibrillators in the United States:
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
The problems associated with these devices caused them to not function as they were intended. In some cases, the defibrillators failed to administer life-saving electric shocks in the presence of serious arrhythmia symptoms. As a result, patients were at a higher risk of death. The FDA suspects that two deaths were caused by these defibrillator malfunctions.
Boston Scientific also recalled similarly malfunctioning defibrillators and pacemakers in 2006. In two cases, patients lost consciousness following a device malfunction relating to these recalled devices:
- VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs (implantable cardioverter defibrillators)
- Certain Insignia and Nexus pacemakers
- CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
Recalling a defibrillator after installation requires surgery
Because surgery is required to replace a malfunctioning or recalled defibrillator, patients must consider these risks carefully before choosing to undergo a surgical replacement. For this reason, some patients may continue to use potentially faulty defibrillators even after a recall.
If you believe that you or your loved one suffered a serious medical event — or death — as a result of a faulty defibrillator, you may want to investigate the type of device involved, whether the FDA recalled it and whether the manufacturer could be to blame for the injuries and/or death. In some cases, victims may discover that they have a viable claim for damages.