Medtronic, a health technology firm, has urged approximately 235,000 patients that have had defibrillators implanted to see their doctors right away as some leads that connect the defibrillator to the heart may be defective.

Affected product

Medtronic’s Sprint Fidelis is the defibrillator model affected. The company began selling the model in the U.S. in 2004. It replaced an early version, the Sprint Quattro, which came out in 2001.

Defibrillators: the basics

Defibrillators, also known as implantable cardioverter-defibrillators (ICDs) or automated implantable cardioverter-defibrillators (AICDs), are small electrical impulse generators that send an electrical ‘shock’ to the heart. The lead that connects the device to the heart is the subject of Medtronic’s recall. According to reports, this defective lead may malfunction in at least one of two ways:

• Fail to shock the heart when a shock is needed
• Shock the heart when a shock is not needed

These malfunctions may have been the cause of at least five deaths already.

Consumer concerns

Consumers that have had a defibrillator implanted are frantic after Medtronic’s announcement and blogs show worried patients wondering if they are affected by the recall. The Food and Drug Administration (FDA) has said that there is no specific test to know if a patient has a faulty lead, but it is recommending that patients see their doctor to determine whether removing the lead or simply capping it – both of which require surgery – is the best option.

Replacements

Medtronic issued a statement that it will pay for a patient to have a defective lead replaced (plus an additional $800 for any non-covered medical expenses). However, experts warn that replacement surgery is risky. Patients that don’t have a defective lead, but are concerned about the quality of the product, are basically out of luck as Medtronic has said that it will not cover the costs in this scenario. Unfortunately, the news for those that qualify for a replacement isn’t all good as Medtronic has also reported that they may not have enough replacements to go around.

Global issue

The recall will affect consumers globally – especially those in Japan as Medtronic only has the Sprint Fidelis device approved for use in that country. The company has not yet reported what it will do in those cases.

If you have been injured as a result of this device, please contact an attorney who can evaluate your case right away. To contact an attorney near you whose practice focuses in this area of law, click here.