Guidant Pacers

The following Guidant pacemakers manufactured between November 25, 1997 and October 26, 2000 are currently under advisory:

Pulsar, Pulsar Max, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intellis II and Contak TR

The Issue: These devices should be air and watertight but can develop a leak. When a leak develops, moisture from the body enters the inside of the pacemaker and can degrade/corrode the internal components.

The Consequences: Should this situation occur, several possible pacemaker errors can occur. These include:

Early battery depletion

Inappropriately fast paced rates up to the maximum rate programmed for the pacemaker (this is due to moisture corrupting the rate sensor)

Reset warning on pacemaker analysis

Sudden failure of the pacing system to pace

The Risks: This failure is rare. As of July 11, 2005, 69 devices of these types have failed out of a total of 78,000 devices manufactured. The risk of these types of devices failing appears to increase with increasing age of the device. If the device is greater then 44 months old, the risk of failure for the remainder of the devices life is estimated by Guidant to be between 0.17% and 0.51%.

Our Recommendations: All patients with these devices need to have consultations with their doctors for individualized medical advise. In general however, we suggest the following steps to take

	Replace the device if the patient is pacemaker dependent (i.e. the device is always working to maintain the heartbeat)
	Consider replacing devices older then 44 months especially if there are other factors suggesting device replacement with a new device will benefit the patient. For example, if a defibrillator or a biventricular pacemaker might provide further benefit to the patient, then the patient should be upgraded sooner rather then waiting for normal battery depletion of the existing device.
	Consider turning off the rate sensor (also known as the accelerometer) of the device at follow-up
	Have the device checked more frequently then usual, especially for devices over 44 months in age.