Lawsuits have already begin after Medtronic’s announcement on Monday, October 15th, 2007 that it would stop selling its Sprint Fidelis product and recall any devices that are already in the market.

Minnesota suit filed

According to reports, patients who had Medtronic’s Sprint Fidelis leads implanted with their defibrillator or pacemaker have filed suit against the company in Minnesota alleging that:

• the product is unsafe,
• it violates several consumer and product liability statutes
• Medtronic misrepresented the product when it knew that the Sprint Fidelis leads could be defective.

The lawsuits are beginning only one day after Medtronic announced that they are recalling the leads and will stop selling them due to data showing that the lead may not work properly. The company estimates that up to 5,000 patients could have implanted leads that are defective.

What is the device?

According to reports, there are three parts to a defibrillator device: 1) the defibrillator itself (a very small metal container), 2) the lead (a wire which connects the defibrillator to the heart) and 3) the programmer that monitors the heart. The device is implanted into a patient and will shock the heart if it begins functioning abnormally. While the first two are actually implanted surgically, the third stays with medical personnel (think of a home security service.)

Consumer / patient information

Medtronic announced that it will pay to have defective leads removed, but that it will not pay to have non-defective leads removed. The issue becomes how to tell whether a lead is defective or not. The Food and Drug Administration (FDA) has said that there is not a specific test to determine this. However, patients are being urged to see their doctor to determine whether the lead should be removed – a procedure that requires surgery and could be quite risky.

Don’t wait

If you or a loved one have an implanted Sprint Fidelis lead, it’s important to first seek medical attention. If you would like to contact an attorney to discuss possible claims against the company, click here and you will be directed to an attorney whose practice focuses in this area of law.