Medtronic Sprint Fidelis leads
In October 2007, the medical technology company
Medtronic issued a voluntary suspension of its Sprint
Fidelis leads, an important part of implantable
defibrillation devices. The lead, a thin wire that
runs from the defibrillator to the heart, allows the
defibrillator device to monitor the patient’s heartbeat.
The lead delivers a lifesaving electrical shock, if
necessary. However, if a fracture or break occurs in the
lead, the signal is interrupted. That may cause the
defibrillator device to release an unneeded and painful
shock or may drain the defibrillator’s battery and cause
it to fail to deliver a lifesaving shock at the
appropriate time. Regrettably, there were numerous
reports of fractures in the Sprint Fidelis leads that
led to serious complications among patients and included
at least five deaths.
The Sprint Fidelis lead is thinner than previous
Medtronic leads, making it easier for doctors to
install, but at the same time it is believed that the
lead’s small size is the cause of the fractures.
According to the Wall Street Journal, even before the
Sprint Fidelis lead went to market, Medtronic received
over 200 reports of lead fractures, but wrote them off
as not statistically significant.
The Sprint Fidelis lead has been implanted in an
estimated 268,000 people worldwide. The lead was used
for other defibrillators besides the Medtronic brand,
including defibrillators made by Guidant and St. Jude.
The Food and Drug Administration urges anyone with a
Sprint Fidelis lead to visit their doctor immediately,
especially if they experience palpitations, multiple
shocks, fainting or lightheadedness. Medtronic states
that while there is a small chance of a fracture in the
lead, it believes that the risk of complications is
higher upon removal and, therefore, patients should only
have the defibrillators removed if their Sprint Fidelis
lead fractures. Sprint Fidelis patients who are not
experiencing problems should still see their doctor to
have the cardiac defibrillator reprogrammed in order to
better monitor and warn of any problems with the lead.
If you or a loved one has been injured due to a Sprint
Fidelis lead fracture, Peterson & Associates can help
you. The law firm of Peterson & Associates has
successfully resolved thousands of cases dealing with
pharmaceutical and medical device manufacturers. Please
contact one of our attorneys immediately for a free
consultation by calling 816-LAW-FIRM, or
click here to fill out an
online form.
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