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Medtronic, Inc. is a Seattle manufacturer of medical devices. On October 15, 2007 it issued a warning to physicians about a family of leads connected to one of its defibrillators and asking them not to use them. The risk is that the lead (wire) might fracture and put the patient at potentially fatal risk.
What is a defibrillator?
A defibrillator is a device that monitors a person’s heartbeat and keeps it regular. To circulate blood effectively throughout the body, the heart needs to pump strongly and regularly, but in some cases of heart disease, it can go into ventricular defibrillation. This means that it pumps too rapidly and ineffectively, so that blood circulation is impaired and the patient’s life is at risk.
This Medtronic defibrillator is implanted near the shoulder and connects to the heart through one or more leads – electrical wires – threaded through veins which travel to the heart. It monitors the heartbeat and when it senses an irregularity, it sends an electrical shock to the heart, which restores regular pumping.
This particular lead is one of a family of leads named Sprint Fidelis, with model numbers of 6930, 6931, and 6949. They were manufactured between September, 2004 and October 14, 2007 and have been used in about 60% of Medtronic’s implantable defibrillators.
If the defective wire were to crack
One or more of three things would happen:
- It might beep, warning the patient to contact his physician at once – and this would not be a problem
- It might send a strong electrical shock to the patient’s chest – which would deliver a tremendous impact and could be fatal
- It might drain the defibrillator battery – which would stop the device from working and could be fatal
About 235,000 people have been implanted with this defibrillator and Medtronic has estimated that about 2.3% (about 4,000 to 5,000 people) could have this lead fracturing within about two-and-a-half years of its being implanted. The company has written warning letters to all of them, advising them to have computerized testing done on their defibrillator wires.
Remove the wires?
Some doctors are in favor of removing these defective leads, but that could be a risky procedure. Why? Because the leads are inside veins, and the body gradually grows scar tissue around them. If the device has been in place for more than about two years, there would be more scar tissue, and removing the lead could cause much bleeding from the vein and even damage to the (already damaged) heart muscle, which could be fatal. If the device has been in place for about six months or less, the risk would be smaller.
An alternative would be to thread a second wire in that vein, connecting it to the heart, and cap off the first one. Medtronic has also offered to reprogram these defibrillators to beep if the lead breaks.
The FDA is considering whether to change the stress tests it has required before these leads are marketed.
You can read more about how we can help on our Defective Medical Devices page.
Most cardiac patients are unaware of what exact defibrillator and exact leads they have implanted in their bodies. If you have an implanted defibrillator and are wondering whether it has a defective wire, please contact your physician as soon as possible. You might also want to contact our personal injury lawyers here at Colling, Gilbert, Wright & Carter, to learn more about your legal rights. We work on a contingency basis, so that you would owe us nothing unless we win an award or judgment for you. So call or email us for a free consultation today.