Medical Device Injuries - Medtronic Defibrillators

Have You Sustained a Personal Injury from a Medtronic Defibrillator?

Medtronic Defibrillator Defect

Implantable Defibrillators

On February 10, 2005, Medtronic began voluntarily notifying physicians about a potential battery shorting action that may occur in Medtronic implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.

In a letter to physicians, Medtronic reported that nine batteries (0.01 percent or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.

More specifically, ICD and CRT-D models with batteries manufactured between April 2001 and December 2003 potentially could be affected. Potentially affected models are the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D devices.

Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.

As part of the company's program to analyze products returned from physicians, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase up to between 0.2 percent and 1.5 percent over the second half of device life.

External Defibrillators

Additionally, on February 25, 2005, Medtronic further announced that it is voluntarily recalling a limited number of LIFEPAK 500 automated external defibrillators (AEDs). The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed.

The LIFEPAK 500 is used by first responders such as firefighters, police and others trained in CPR/AED use and are first to arrive at the scene of a cardiac incident but do not have significant medical training.

U.S. Food and Drug Administration (FDA) has been apprised of this action and has classified the Medtronic Recall as a Class I Recall. The FDA defines Class I recalls as the most serious type of recall, and involves situations in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Medtronic Announces Voluntary Recall of Certain Monophasic LIFEPAK 500 Automated External Defibrillators
Medtronic Warning Letter from Department of Health
Medtronic Defibrillator Situation Overview

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Personal Injury

Injuries to one's person can occur in numerous different ways. In addition to car & automobile accidents, there are many other examples of situations that would provide a legal basis for personal injury claims. These include negligence towards others, as in medical malpractice claims and patient neglect in nursing home and healthcare facilities. Additionally, any person or business can be negligent of adequatley maintaining their property which may result in slips and falls or other accidents; and criminal incidents that may occur because of negligent security. Also, people can be injured as the result of intentional attacks, such as in the cases of dog bites or assault and battery.

Injuries to property can happen due to theft/vandalism, embezzlement, and negligence, while injuries to one's reputation typically occurs as the result of libel or slander.

When a person suffers an injury to his person, rights, reputation, or property, they may be entitled to compensation and should consult a lawyer immediately. In addition to Personal Injury claims needing to be filed within specified time periods, over time, critical evidence can dissipate making claims harder to prove.

An injured party may be entitled to recover damages for loss of earnings capacity, pain and suffering, and reasonable medical expenses, including both current and projected future losses.