DEFIBRILLATOR AND PACEMAKER OVERVIEW

As the need rises for implantable cardioverter defibrillators (ICD) and pacemakers for heart patients, more recalls are being issued for these devices. According to a study led by a Harvard Medical School instructor, “pacemaker and ICD recalls and safety alerts occur frequently, affect many patients, and appear to be increasing in number and rate.” Between 1990 and 2000, the FDA issued 52 advisories related to popular pacemakers and defibrillators.

An ICD, or implantable cardioverter defibrillator, is an electronic device that monitors your heart rate and rhythm. When the defibrillator detects an abnormal heart rhythm, it delivers a shock to the heart muscle to restore a normal rhythm again. Then the device goes back to monitoring mode. Many ICDs record patterns of an abnormal heart rhythm, which can later be reviewed by the heart patient’s doctor to aid in planning future treatment options. Defibrillators are small devices that are implanted under the heart patient’s skin. Then wires attached to the defibrillator are threaded through the blood vessels from the defibrillator to the heart muscle.

A healthy heart has its own pacemaker that regulates the rate in which the heart beats. However, some heart rates don’t beat regularly and often a pacemaker device can correct the problem. A pacemaker is a small, battery-operated device that sends electrical impulses to the heart muscle to maintain a suitable heart rate and rhythm. Like the defibrillator, these devices are implanted and wires are threaded into the heart and implanted into the heart muscle. Pacemakers send shocks that pace the heart if the rate falls below a certain preset level in order to maintain a heart rhythm.

While defibrillators and pacemakers are life saving devices in many instances, recalls and advisories linked to these devices are not uncommon. A Guidant recall recently announced that nearly 50,000 heart defibrillators could short circuit without warning. As a result of the short circuit, the Guidant defibrillator can fail to deliver the necessary shock to the heart. Medtronic began warning doctors about some faulty batteries installed in a line of its implantable heart defibrillators - causing the battery to experience a rapid depletion of power resulting in the loss of the Medtronic defibrillator function.

If you or a family member have a defibrillator or pacemaker subject to a recall it is critical to contact your health care provider to determine the steps you should take in protecting your health. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact us directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.