Just over two months ago Medtronic warned doctors and about
250,000 patients that a lead that is used to connect a
defibrillator to the heart could potentially fracture. The
leads, called Sprint Fidelis, were recalled by Medtronic on
October 15, 2007 after reports of fractures, unnecessary
shocks, and death. While Medtronic has said that most
patients do not need to have their leads replaced, but this
has not assuaged the thousands of patients who have these
leads implanted.
On December 13, 2007 the New York Times published an
article chronicling the plight of these defibrillator
patients with recalled Sprint Fidelis leads. These patients
are living in fear that their defibrillator may start to
shock them when he is not required to do so, or not provide
the life-saving shocks is supposed to when it is necessary.
Making matters more complicated, Medtronic is not paying
for these patients to have their leads replaced. The New
York Times said that Medtronic is only providing $800
towards these patients lead replacement surgery. The cost
of this type of surgery is typically $12,500 or more.
Putting the financial component aside, lead replacement
surgery is risky. The Times article talks about a
48-year-old patient who opted to have the lead replaced.
The reporter described the replacement e as a "painstaking
90-minute operation". Medtronic says most patients will not
need to have their leads replaced. Instead, they recommend
that these patients have their defibrillators reprogrammed
to improve the odds of discovering a fractured lead early
on. However, many patients don't feel comfortable with a
strategy of just trying to catch the fracture early, and
are seeking second opinions from doctors who specialize in
defibrillator lead replacements.
In an ironic twist, many of the patients are replacing
their defective Sprint Fidelis leads with another Metronic
lead, the Quattro. This shift back to the Quattro lead has
helped Medtronic make up for much of its lost sales of
Fidelis. Since Medtronic is only contributing $800 towards
their patients lead replacement surgeries, the company
actually stands to profit off of these unfortunate patients.
According to several law firm websites, patients that have
recalled defibrillators may have legal rights. Over the
past few years thousands of cases were filed against
Medtronic and Guidant, another large defibrillator
manufacturer, after the companies recalled several
defibrillator models. Guidant was purchased by Boston
Scientific in 2006, after outbidding Johnson & Johnson for
the company.
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On October 15, 2007 Medtronic recalled its Sprint Fidelis
defibrillator leads from the worldwide market. The leads
were recalled after numerous leads fractured causing the
attached defibrillator to provide unnecessary shocks.
Patients who have these leads implanted are extremely
concerned because lead replacement surgery is risky and
expensive. http://www.medtronicsprintfidelis.com
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