Sprint Fidelis Problems Weigh On MedtronicDec 31, 2009 | Parker Waichman LLP
We have long been writing about the dangerous, sometimes deadly, issue regarding defective cardiac device leads. Now, a report out by UBS Investment Research announced that, “lead failures could accelerate over time,” said Med City News.
Lead wires are placed into a major vein and attached to interior heart muscle for the purpose of monitoring heart rhythm and transmitting electric shocks should an irregularity occur. If a lead breaks, the implantable cardiac defibrillator (ICD) can emit a massive and painful shock. And, in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart.
The Sprint Fidelis lead was removed from the market in October 2007 following reports of deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, according to a recently filed lawsuit. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record previously.
Replacing a lead is dangerous and the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture; a choice with which many patients are uncomfortable. According to a prior report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.
We recently wrote that three additional lawsuits were filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations by three patients in a 60-count suit. This may only be the tip of the iceberg for both Medtronic and the industry. Med City News says that the huge recall has cost Medronic in a variety of ways, including legal bills and a drop in sales. More is expected, not only for Medtronic, but the industry as a whole.
The UBS report referred to studies that say lead failures could reach an alarming 30 percent within four years, said Med City News, which added that Medtronic data states a three percent failure rate in three years. “’Fidelis may cast a long shadow’ over the $5 billion ICD market,” said the report, quoted Med City News. Of significant note, another study found that healthy patients are at greater risk of lead failure because of their expected longevity, said Med City News.
The report also stated that “Experience with Fidelis may support tougher regulatory process,” referring to U.S. Food and Drug Administration (FDA) approval for Class III devices via pre-market approval (PMA) supplements, quoted Med City News. Class III devices are considered the riskiest. Of concern is that a PMA supplement approval for a Class III device is considerably easier to obtain versus other Class III-type applications, which was a problem in the case of the Sprint Fidelis since improvements to the leads were touted as “minor changes” and enabled Medtronic to seek a PMA supplement (Sprint Fidelis was approved under a PMA supplement, not a new PMA) leaving experts at a loss to describe what qualifies as a minor change.