Information Update - Rare risk of cardiac strangulation in children with epicardial pacemaker leads

OTTAWA, Oct. 17, 2012 /CNW/ - Health Canada is advising health care professionals and the public of a rare potential risk of cardiac strangulation for children implanted with epicardial leads connected to a pacemaker. These leads (wires) are fixed on the outer surface of the heart. With the child's growth, the leads can compress the heart, which can result in cardiac strangulation.

The epicardial pacemaker leads are implanted in children with cardiac rhythm abnormalities for which pacing therapy is essential.

Symptoms of cardiac strangulation greatly vary among patients. Heart compression by the leads can cause chest pain, general fatigue, fainting as well as signs or symptoms of heart failure. Parents of children implanted with epicardial pacemaker leads should be aware of these symptoms and speak with their doctor if they notice any of them or if they want additional information regarding this risk.

Health Canada has been made aware of rare Canadian cases of cardiac strangulation in pediatric patients implanted with epicardial pacemaker leads. Eight international cases of cardiac strangulation, including two deaths, have been reported in medical journals. In some cases, cardiac strangulation was diagnosed early and the patients underwent successful corrective surgery to replace the lead.

Health Canada will continue to monitor this issue and will inform health care professionals and Canadians as needed.

Canadians should report any incidents or adverse events associated with the use of epicardial pacemaker leads to:

Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario, K1A 0K9
Telephone: The Inspectorate Hotline: [phone]

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Website.

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SOURCE: Health Canada

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