Medtronic Defibrillator / Pacemaker Recall

Defective Medtronic devices can experience rapid battery failure and loss of device function in as little as a few hours. Consequences of malfunction can be fatal.

In February of 2005 Medtronic, Inc., a leading manufacturer of cardiac pacemakers and Implantable Cardiac Defibrillators or ICDs, issued a voluntary advisory concerning premature battery depletion in their devices. In a letter to physicians, Medtronic reported that batteries in these devices had experienced rapid battery depletion due to a battery shorting mechanism. When shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function without warning to the patient.

According to the advisory from Medtronic, “devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action”. The devices Medtronic identified as potentially affected are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices. According to Medtronic, approximately 75 percent of these devices were implanted in patients in the United States.

Risks to Medtronic Defibrillator & Pacemaker Patients

heart-rhythm-pacemaker Defibrillator and pacemaker devices are implanted in patients who have been diagnosed with certain heart problems resulting in life-threatening irregular heartbeat. The devices are designed and intended to deliver “pacing therapies”, including electrical shocks to the heart when necessary to restore a normal rhythm pattern.

Because defibrillator and pacemaker recipients are medically dependent on the continued functioning of their devices, failure of the device can be devastating. Defibrillators and pacemakers serve as life-saving devices when they function properly. When they fail the results can be fatal. Failure of the devices to deliver a required shock has in some cases resulted in the death of the patient.

Many patients who received defective Medtronic defibrillator and pacemaker devices were notified by their physicians of the recall and had to undergo additional surgeries to remove and replace the original device. In certain instances, the replacement device was included in a later recall by Guidant Corp. In the most distressing cases, the patient and their family were unaware of the defect until the device failed to work and the patient faced a serious medical condition, or in some cases, died.

Injured by a Defective Medtronic Device?

If you or a family member received a defective Medtronic device, or have been injured due to a defective pacemaker or defibrillator, you may be entitled to compensation from those responsible for the injury. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large medical device manufacturers like Medtronics and hold them accountable for their actions.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

More Information on Defective Medtronic Defibrillator Devices

Medtronic Issues Notification Regarding Certain Implantable Defibrillator Models

FDA.gov – February 11, 2007