Defibrillator Lead Replacement Surgery Could be Fatal

By: Joel Simon

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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