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From the Food and Drug Administration
December 5, 2001

Remote Data Pacemaker

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Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001American Medical Association

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JAMA. 2001;286(21):2660. doi:10.1001/jama.286.21.2660-JFD10012-3-1

The FDA has approved Home Monitoring (Biotronik Inc, Lake Oswego, Ore), a modified implantable pulse generator (IPG) with an added capability for instantaneous or periodic remote transmission of patient diagnostic data. The new pacemaker was approved for rate-adaptive pacing in patients with chronotropic incompetence who would benefit from increased pacing rates concurrent with physical activity.

The remote communication system consists of an implanted low-power radiofrequency circuit that automatically and regularly transmits data from the IPG to an external cell phone–like "patient device" that is carried by, or placed near, the patient. The patient device uses the cell phone network to transmit the data to the manufacturer's service center, which stores, correlates, and periodically faxes them to the patient's physician. Data transmissions from the IPG can be programmed to occur at intervals ranging from 1 to 30 days.

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