The Winnipeg Regional Health Authority is contacting about 100 people in the Winnipeg area who have defibrillators with potentially defective wires attached to them.
The manufacturer, Medtronic Canada, says wires attached to the implanted heart devices could break, which could cause the administration of too many or too few electronic shocks, health authority officials said Tuesday.
The notice affects only defibrillators implanted after January 2004 with Sprint Fidelis defibrillation leads with one of the following model numbers: 6930, 6931, 6948 or 6949.
Every patient with an implanted defibrillator should have a Patient ID card that displays its model number. Patients who have misplaced their cards or who have other concerns can call the health authority’s inquiry line at (204) 788-8004 for more assistance.
Callers will be required to leave a recorded message with their name, date of birth, personal health information number and any questions.
Family physicians and emergency rooms have also been alerted, in case any affected patients turn up at their offices.
The Winnipeg Regional Health Authority is contacting all affected patients by phone and by letter and will set up followup clinic visits where required.
The defibrillator system consists of a device implanted near the shoulder and one or more leads connecting the device to the heart.
Minneapolis-based Medtronic Inc. withdrew the lead wires last week because of fracture problems that may be linked to five U.S. deaths.
More than 268,000 leads currently are in use, including about 6,000 in Canada.