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Medtronic Pacemakers

Defects, Recalls and Lawsuits

A pacemaker is a medical device that is surgically implanted to help a patient with an irregular heart rhythm or slow heart rate. When a pacemaker senses a problem it sends electrical energy to the patient's heart in order to re-establish a normal rate and rhythm. If a pacemaker does not function properly, it can have serious or even fatal consequences.

Medtronic, one of the oldest and largest cardiac device manufacturers in the world, is credited with developing the first wearable and implantable pacemaker devices. A staggering 1.7 million of their popular Kappa and Sigma series devices alone have been implanted worldwide. However, in recent years the company has issued multiple recalls affecting Kappa and Sigma Series pacemakers due to a wiring problem that could cause partial or even total device failure. Medtronic has admitted that hundreds of the device failures and at least two deaths are associated with this defect.

If you or your loved one suffered injuries from a Medtronic pacemaker, you may be entitled to compensation for pain and suffering, rehabilitation and medical expenses, lost wages, punitive damages and wrongful death. Many medical device lawsuits result in substantial settlements. Contact an injury lawyer who specializes in personal injury to learn more.

Medtronic Pacemaker Defects

According to Medtronic, the problem with their Sigma Series pacemakers originated during the manufacturing process because of a cleaning solvent that was used on the hybrid circuits. The solvent could weaken the interconnect wire bond and result in separation from the hybrid circuits. If separation occurs, the device may experience one or more of the following:

  • Loss of rate response
  • Premature battery depletion
  • Intermittent or total loss of telemetry (heart rate and rhythm monitoring)
  • No output

Side Effects of Pacemaker Surgery

If you have a Medtronic pacemaker, your physician may recommend replacing your device. According to the National Institutes of Health (NIH), some of the risks associated with pacemaker surgery include:

  • Swelling, bleeding, bruising, or infection at the surgical site
  • Blood vessel or nerve damage
  • A collapsed lung
  • A negative reaction to anesthesia
  • Infections that become difficult to treat

If you have undergone or need to undergo replacement surgery, you may wish to speak to an attorney about your right to receive compensation.

If the device is defective, symptoms of a slow or irregular heartbeat may re-occur, such as weakness, shortness of breath, lightheadedness, loss of consciousness and other, more serious symptoms. Patients who experience any of these symptoms are advised to seek medical attention immediately.

Medtronic has admitted it has no way of identifying which of the devices in the target population are most likely to fail. As a result, patients have to choose between leaving a device with a potentially fatal defect implanted in their body versus undergoing an invasive surgical procedure to replace the device. If you have or had a Medtronic pacemaker, you may wish to speak to a personal injury lawyer who has experience negotiating settlements and filing lawsuits aimed at obtaining financial compensation.

Medtronic Pacemaker Liability

Pacemakers are classified by the Food and Drug Administration (FDA) as Class III medical devices, the most stringent regulatory category of devices. If Medtronic misled or withheld information from the FDA, or failed to make the device in strict accordance with FDA approval, they may be liable for harm or defective product deaths caused by their device.

Update on Medtronic Device Recalls

In November 2005, Medtronic recalled approximately 40,000 Sigma Series pacemakers after 19 reports of problems related to faulty wiring.

According to Medtronic modeling, they expected a failure rate between 0.17 and 0.30 percent over the remaining lifetime of these pacemakers. But in May 2009, Medtronic revised this figure upward to 3.9 percent over the lifetime of the remaining 15,600 implanted devices.

At that time, Medtronic also issued a new recall of 15,200 Kappa series pacemakers and another 6,100 Sigma series devices for the same defect. The Sigma series has a predicted failure rate as high as 4.9 percent. Medtronic is now advising physicians to consider device replacement for patients who are both pacemaker dependent and have one of the 36,900 affected devices that remain in use.

Additionally, Medtronic may be liable for a defective medical device under product liability law. A defective medical device is generally defined as unreasonably dangerous when there is a problem with its design, manufacturing or warnings and instructions for use. For example, Medtronic's use of the cleaning solvent may be evidence of a manufacturing defect. Most states allow strict liability claims against manufacturers and suppliers of dangerous medical devices. Strict liability means you do not need to prove the defendant was negligent, only that the device was unreasonably dangerous and was the cause of harm.

Filing a Lawsuit

The laws concerning defective medical devices are complex and subject to change. If you or a loved one has had a Medtronic pacemaker, a product liability attorney can determine how the laws apply to your specific situation. Product liability attorneys who handle defective medical device lawsuits and settlements usually operate on a contingency fee basis. This means that you will have no upfront expenses and the lawyer will cover the cost of the case, win or lose. The lawyer only receives an agreed upon percentage of any damages recovered if you win the case.

If you believe you or a loved one has been injured by a Medtronic pacemaker, you should contact a personal injury lawyer or wrongful death attorney as soon as possible to discuss the possibility of filing a claim for compensation.

[Last revision: August 5, 2010]



FACT:

Bradycardia, or abnormally slow heart rate, is generally defined as less than 60 beats per minute, though healthy athletes often have heart rates well below this. A normal heart rate is around 72 beats per minute.