Canadian heart rhythm specialists comment on Medtronic Sprint Fidelis lead issue

    QUEBEC, Oct. 23 /CNW Telbec/ - Meeting at the Canadian Cardiovascular
Congress in Quebec City, the Canadian Heart Rhythm Society (CHRS), a
professional group representing Canadian heart rhythm specialists, issued a
statement today on the recent concerns about the Medtronic Sprint Fidelis
family of implantable cardiac defibrillator (ICD) leads (Models 6930, 6931,
6948 and 6949).
    "The Canadian Heart Rhythm Society has been working with Medtronic Canada
to communicate the perspective of our members on this issue, and to seek
clarification regarding the nature of the concern, the risks posed to our
patients, and potential solutions," said Dr. Martin Gardner, President of
    Medtronic Canada sent a letter to Canadian doctors on October 15th, 2007
regarding an issue with the Medtronic Sprint Fidelis family of ICD leads
(Models 6930, 6931, 6948 and 6949). The letter was sent in response to a
growing concern regarding a small risk of a crack developing in the wire that
connects the defibrillator to the patient's heart. Five deaths worldwide are
currently under review, in which the lead may have been a possible or likely
contributing factor.
    Medtronic estimates that 5,955 potentially affected leads have been
implanted in Canadian patients since the leads were released in 2004.
    "We don't want to alarm patients unnecessarily," said Dr. Andrew Krahn,
Chair of the CHRS Working Group on Device Advisories. "New implantations of
these leads have been suspended, and so far the reported leads affected in
Canada are around 1% of the total implanted. That said, it's important that
patients be aware of the problem, and discuss the issue with their
    The CHRS has posted a suggested letter on its web site,, for physicians to use in notifying their patients, and is
urging professionals to do so right away. They issued a summary and
recommendations, targeting health professionals, which is also available on
the web site.
    Dr. Charles Kerr of the Canadian Cardiovascular Society supported the
CHRS efforts to inform professionals and their patients. "It's very important
that doctors and their patients have access to timely information on the
problem, the risks and the solution. CHRS is providing an important service
with this statement."
    The problem in question can cause inappropriate shocks, and much less
frequent potential problems with the delivery of life-saving high-energy
shocks. Routine monitoring may not detect the problem, but devices can be
reset to improve the chances of detecting changes in lead performance before
the patient experiences a shock.
    "It's also important that we recognize that for most patients, the risk
of lead replacement would greatly exceed the risk of non-replacement unless
there is evidence of lead malfunction," noted Dr. Krahn. "Lead replacement is
not generally recommended, but these decisions need to made on a case by case
basis by doctors."
    "The CHRS has been communicating with its members and working in
collaboration with Medtronic and Health Canada to take action and get this
message out broadly. The safety of our patients is our paramount concern,"
said Dr. Gardner of the Society.

    Canada's heart rhythm specialists, represented by the Canadian Heart
Rhythm Society, are committed to the promotion of evidence-based practice in
Canada. The full text of the CHRS statement on Medtronic Sprint Fidelis leads
is available at

For further information:

For further information: For interviews (Oct 23) please contact the
media room at the Canadian Cardiovascular Congress at (418) 649 5215; Dr.
Andrew Krahn (519) 318-8787 (cell); Dr. Martin Gardner (902) 221-4747 (cell)

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