After Correcting Battery Depletion Issue, St. Jude Continued to Sell Old ICDsNov 2, 2016
St. Jude says it continued to ship old versions of its heart devices after the company implemented a design change that prevents premature battery failure. Ultimately, early battery depletion has prompted the devices, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to be recalled. Various models of Fortify, Unify and Assura were affected by the recall.
ICDs and CRT-Ds are heart devices implanted under the skin in the upper chest. They provide electrical shocks or pacing in patients who have an abnormal heart rhythm. However, these pacemaker devices have been recalled due to a battery defect that can cause the battery to deplete much sooner than expected. The U.S. Food and Drug Administration (FDA) recently designated the recall as Class I, the agency's most serious recall status. Class I recalls indicate that exposure to a recalled device can lead to serious injury or death.
The defect stems from the buildup of lithium within the battery. If a lithium cluster happens to form between the two main components of the battery, the anode and cathode, then it can cause a short circuit where the battery depletes rapidly. According to StarTribune, St. Jude learned of the issue in a December 2014 journal article. The company changed the design of the battery in May 2015. The FDA approved the design change, which involved adding an internal barrier to reduce the risk of lithium building up in a way that could cause a short circuit. When the design change was approved, St. Jude was not required to recall its older models.
"Available data available regarding the rate of overall adverse events indicated the risk to patients was low and was considered consistent with overall rates observed with other makes and models of implantable defibrillators," said FDA spokeswoman Deborah Kotz, according to Qmed. "Manufacturers are not required to initiate a device recall for changes to medical devices that are not in violation of the Federal, Food, Drug and Cosmetic Act (FD&C Act)."
St. Jude continued to sell the older versions of its ICDs and CRT-Ds for 17 months after the design change. The company claims it had no way of knowing the issue would lead to a recall affecting 350,000 devices worldwide.
In patients who are dependent on ICDs and CRT-Ds, the battery depletion issue can be life-threatening. Usually, patients have three months to replace the battery once an alert goes off, but St. Jude has received reports where the battery dies almost immediately after the alert. Two patients died when the batteries in their heart devices failed to deliver therapy.
According to StarTribune, some physicians are concerned about the timing of the recall. Doctors found out about the battery issue at almost the same time as consumers. As a result, they unknowingly implanted heart devices with older versions of the battery. This was the case with Dr. Kevin Campbell, a cardiac electrophysiologist in North Carolina who feels St. Jude should have taken older devices off the market. "I'm very angry because those patients put their lives in my hands," said Dr. Campbell, according to StarTribune. "If it's a big-enough deal to change the manufacturing process, then pull it off the shelf."
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