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Medtronic Sprint Fidelis® Cardiac Leads Linked to Serious Harm, Death
On October 15, 2007, Medtronic removed its Sprint Fidelis® heart defibrillator cardiac leads from the market after reports surfaced that linked the leads to patient deaths (1).
The Medtronic Sprint Fidelis is an electrical wire that connects implantable cardioverter-defibrillators (ICDs) to the heart. This wire is called a “lead.” Defibrillators (ICDs) monitor the rhythm of the heart and will deliver an electric shock directly to the heart if it begins to beat dangerously fast (1).
Why were sales of the
cardiac leads suspended?
The cardiac leads in question are placed on the heart’s muscles and then attached to a device implanted in the body that is designed to maintain an appropriate heartbeat. These leads, however, may break down and deliver unnecessary, painful, and life-threatening shocks to people who have them implanted in their heart muscles.
“These electronic wires are prone to fracture,” says the Food and Drug Administration (FDA) in a recently-released statement, and this fracture “can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured (2).”
How many people may be affected?
Medtronic said 235,000 people have these Sprint Fidelis cardiac leads in their bodies (1).
What models are affected?
The affected models are in the “Sprint Fidelis” family of
Medtronic leads. The affected model numbers are 6930, 6931, 6948, 6949 and
these encompass ALL Sprint Fidelis models (1). These were manufactured between September 2004 and October 2007.
What should I do if I have a Medtronic heart device that may be affected?
According to the FDA, “Neither FDA, Medtronic, nor representatives
of the Heart Rhythm Society recommend the routine surgical removal of a
fractured lead because removal carries risks. Instead, physicians should weigh
the benefits and risks of either continuing to use the lead with careful
monitoring or capping the lead so it is no longer usable and implanting a
different model.”
If you or someone you care about has suffered as the result of a heart device misfiring and causing serious harm or death, or if the device failed to work as intended, call our law firm for a free and confidential evaluation of your case. We want to help.
1) "Medtronic Recalls Sprint Fidelis Cardiac Leads, Questions and Answers for Consumers" from the Food and Drug Administration. Accessed 10/17/07 via www.fda.gov.
2) "Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads" from the Food and Drug Administration. Accessed 10/17/07 via www.fda.gov.
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