Guidant Issues Warning on Pacemakers

To limit adverse events, Guidant Corp. (Indianapolis, IN, USA) has initiated communications to doctors worldwide regarding potential problems with the company's pacemakers.

The pacemakers in question are of an earlier generation design and have not been sold or implanted for four years. These devices are sold under the following names: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR. Guidant has determined that a hermetic sealing component in these devices may experience a gradual degradation, resulting in a higher-than-normal moisture content within the pacemaker case late in the device's life.

As of July 11, 2005, Guidant had identified 69 devices that may have exhibited this failure mode, out of a total of 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time. Based on field experience, Guidant estimates the rate of failure in the remaining active implanted devices to be between 0.17% and 0.51% over the remaining device lifetime.

In deciding the best course of action, Guidant recommends that doctors consider the unique needs of individual patients. The company recommends that doctors consider replacing devices for pacemaker-dependent patients. Many of the devices are nearing or have exceeded their estimated longevity and have thus outlived their warranty. Guidant will provide a replacement device at no charge for pacemaker-dependent patients and others deemed by their doctors to best served by replacement. Only several weeks ago, Guidant was forced to announce recalls of certain of its implantable defibrillators.

"The health and safety of patients is paramount,” stated Ronald W. Dollens, president and CEO, Guidant Corp.




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