Epicardial Pacemaker Leads - Risk of Cardiac Strangulation in Pediatric Patients with Implants - Notice to Hospitals

Starting date:

October 15, 2012

Posting date:

October 17, 2012

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-15078

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Epicardial Pacemaker Leads in Children

October 15, 2012

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Cardiology, Cardiac Surgery, Pediatrics, Pediatric Cardiology, Pediatric Cardiac Surgery, Emergency, Intensive Care and other involved professional staff and post this NOTICE in your institution.

Subject: Risk of Cardiac Strangulation Associated with Epicardial Pacemaker Leads Implanted in Pediatric Patients

Health Canada would like to inform you about the potential risk of cardiac strangulation, a rare adverse event associated with epicardial pacemaker leads implanted in pediatric patients. As the child's heart grows, the leads can compress the heart and/or coronary arteries which can result in cardiac strangulation. The placement and routing of the lead to the pacemaker appear to contribute to this potentially severe adverse event.

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 fatalities, have been reported in the scientific literature. In some cases, cardiac strangulation was diagnosed early and the patients underwent successful revision surgery.

• As the child's heart grows, the epicardial pacemaker leads can compress the heart and/or coronary arteries and cause cardiac strangulation which can result in a life-threatening condition or death.
• Signs or symptoms of myocardial infarction or heart failure should prompt further clinical investigation and cardiac strangulation should be suspected in pediatric patients implanted with epicardial leads.
• Particular attention should be taken for the appropriate placement and routing of the lead to the pacemaker in order to reduce the risk of cardiac strangulation.

The clinical presentation of cardiac strangulation greatly varies among patients. Signs and symptoms associated with cardiac strangulation, that have been reported in the scientific literature, include chest pain, general fatigue, syncope, symptoms of myocardial infarction and heart failure and a new cardiac murmur.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of cardiac strangulation or other serious or unexpected adverse incidents in patients using epicardial pacemaker leads should be reported to Health Canada at the following address:

Any suspected adverse incident can be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline: 1-800-267-9675

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

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738