Who will be able to forget 2007 -- the Year of the Recall?
You name it and – it – has been recalled: pet
food, peanut butter, toys, spinach, more pet food, airbags,
cars and trucks, more toys, chicken pot pies, bicycles,
ground beef, pharmaceutical drugs…the list is
endless. On any given day the FDA (Food and Drug
Administration), the CPSC (Consumer Product Safety
Commission), and NHTSA (National Highway Traffic Safety
Administration) have recalled and recalled.
While these recalls are all serious and often deadly, they
are not as invasive as a connecting device implanted into
the body during defibrillator surgery.
First, a little heart device 101: There are different kinds
of defibrillators. The first is portable used at sporting
events and on airplanes. Another is used in hospital
settings; defibrillators send voltage through two paddles
that doctors place on a heart attack victim's chest area.
The invasive defibrillator is implanted into people to
regulate their heartbeat by shocking the victim's heart to
restore the normal rhythmic patterns. When a defibrillator
is used, it in effect kicks the heart into action again, by
resuming pumping blood throughout the body.
Part of the defibrillator is known as the lead. It is a
connecting insulating wire threaded through the veins. The
lead stretches from the computerized device implanted near
the collarbone to the heart, where it is secured into the
heart muscle with screws. Electrical signals from the heart
travel through the lead to the device, and the device sends
its shocks, when needed, back through the same lead. The
problem with the Medtronic Sprint Fidelis lead is that it
breaks or cracks. When the lead breaks or cracks the device
starts to receive electrical noise and thinks the heart is
not beating correctly. A pacemaker might send a tiny shock
to the heart, but with defibrillators, patients can really
feel the power. A defibrillator out of whack can make a
person feel like they are being repeatedly struck by
lightning.
As of October 4, 2007, there were approximately 268,000
Medtronic defibrillator Sprint Fidelis leads implanted
worldwide. There have been five patient deaths. So far
Medtronic has confirmed 665 chronic fractures in returned
leads on model numbers 6930, 6931, 6948 and 6949.
There is a recall on all unsold Sprint Fidelis leads but
what options are available for the 268,000 people who have
these implanted heart leads?
Even though Medtronic considers itself the world leader in
medical technology by providing lifelong solutions for
people with chronic disease – Sprint Fidelis is not
its first recall heart implantable devices. In 2005,
Medtronic identified nine of 87,000 implanted devices (0.01
percent) with a battery design that exhibited this shorting
mechanism. Based on highly accelerated company testing,
Medtronic estimates that this rate may increase up to
between 0.2 percent and 1.5 percent over the second half of
device life.
Medtronic recommends that doctors more closely monitor
their patients with Sprint Fidelis leads. Medtronic does
not recommend that the Sprint Fidelis leads be removed
because the surgery can be difficult or fatal.
In the meantime, what do the 268,000 people already
implanted with Sprint Fidelis leads do?
----------------------------------------------------
If you have a Sprint Fidelis lead connecting to your
defibrillator, you may need the services of a personal
injury law firm. If a loved one has been injured or already
died from a Sprint Fidelis heart lead wire, please contact
Anapol Schwartz at http://www.anapolschwartz.com for a free
consultation with a wrongful death personal injury law
firm. More info on the lead recall can be found at
http://www.anapolschwartz.com/practices/sprint-fidelis/ .
No comments:
Post a Comment