Advisory

2005-85
August 4, 2005
For immediate release

Health Canada advises Canadians about risks associated with Guidant pacemakers

OTTAWA - Health Canada is advising Canadians who have implanted PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN, PULSAR MAX II, DISCOVERY II, and CONTAK TR pacemakers, manufactured by Guidant Canada Corporation, that certain units may be prone to a gradual deterioration of a seal in the device. This may lead to premature battery depletion and malfunction of the pacemakers. Health Canada was informed of the recall of these devices by the manufacturer on July 15, 2005.

The affected pacemakers were manufactured between November 25, 1997 and October 26, 2000. Guidant reports that there are 1,622 of these devices in service in Canada. The company has issued a letter to physicians informing them of the need to monitor their patients and take appropriate action based on the unique needs of each patient.

Patients with one of these pacemakers are advised to consult with their physicians regarding any risks to their health. Patients should seek immediate medical attention if they notice a prolonged rapid heart rate, lightheadedness, or have new or increased symptoms of heart failure such as shortness of breath, fatigue, confusion or nausea.

Health Canada was informed of this issue by the manufacturer on July 15, 2005. Health Canada is aware of one non-fatal device failure in Canada associated with the recent Guidant action and continues to monitor the effectiveness of the recall of these products. Approximately 28,000 of these pacemakers remain implanted worldwide. Fifty-two cases of malfunction have been confirmed worldwide. Health Canada is not aware of any deaths associated with the malfunctioning of these pacemakers.

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Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250

Public Inquiries:
(613) 957-2991