Electrophysiology devices made by Minneapolis-based St. Jude Medical Inc. are back in the bad news column due to an unexpected depletion of batteries the company said is associated with a buildup of lithium deposits. The problem could lead to complete battery failure within an hour of the sounding of an alert, but Wall Street sees the problem as limited as demonstrated by the fact that the announcement drained only about three percent from the value of the company's shares at the New York Stock Exchange.

One of the first sources to break the story was Muddy Waters Research LLC, the investment research firm that previously had disclosed information about the possibility that St. Jude's pacemakers and defibrillators could be hacked. That information is reported to have come to Muddy Waters from cybersecurity start-up Med Sec, and Muddy Waters disclosed the information in August and took a short position on St. Jude stock. That disclosure shaved seven percent from St. Jude's share prices.

The reports of battery problems come at a particularly sensitive time given the impending acquisition of St. Jude by Abbott Park, Ill.,-based Abbott Laboratories, which would represent a per-share value of roughly $85 for a total value of $25 billion. An investor's note from senior analyst Larry Biegelsen of Wells Fargo noted that two physicians had advised Biegelsen that the problem with the batteries in implantable defibrillators and cardiac resynchronization therapy devices "would have a modest negative impact" on the company's shares despite any reaction from cardiologists.

However, Biegelsen pointed out that St. Jude does not yet have any pacemakers or ICDs labeled as MRI-compatible, an increasingly important segment of the EP market, and that ICD sales will account for roughly one quarter of St. Jude's revenues for 2016. St. Jude ran into a problem with cardiologists over problems associated with the company's Riata line of EP leads, which the company withdrew from the market in 2010. The associated lawsuits were settled in early 2015 for roughly $15 million.

The battery problem affects nearly 399,000 units manufactured prior to May 23, 2015, all from the Fortify, Quadra, and Unify lines of devices. Approximately 840 of these were returned to St. Jude for analysis, and 46 of those units are said to have exhibited lithium clustering between the cathodes and anodes, with the obvious implications for short circuit. Two deaths have been reported in association with the problem, but it is not clear whether St. Jude was manufacturing the batteries in-house. At present, roughly 350,000 of the devices remain implanted in patients or are otherwise unavailable to the company.

The FDA issued an Oct. 11, 2016, alert stating that the device should be replaced immediately upon activation of the elective battery replacement indicator alert. The agency said there is no known method for determining when a battery associated with an alert would fail, and that depletion would not necessarily be universally reported to the FDA or the manufacturer, leading to some uncertainty as to the true rate of premature battery depletion. The agency did not recommend prophylactic device replacement as the rate of complications associated with device replacement exceed those associated with battery depletion. Inspection of firm associated with recall

A November 2015 inspection of Collagen Matrix Inc. (CM), of Oakland, Calif., for the company's manufacture of its Zcore porcine xenograft particulate (syringe form) was followed by a March 14, 2016, recall, suggesting that the inspection drove the recall. The Sept. 20, 2016, warning letter to Collagen Matrix (CM) made note of issues associated with design validation, but the agency also said the company made changes to the device without filing a new 510(k) despite that the changes could have affected the device's safety and efficacy profile.

The class III recall of the device was prompted by reports that the syringes used with the device, a matrix used in bone reconstruction following dental surgery, did not dispense the device readily. The distributor of the device had advised customers to quarantine any unused product, 200 of which had been distributed in the state of Texas. The warning letter stated that CM had received several complaints regarding the syringes, and that the design verification/validation studies failed to establish that the device/syringe combination comported to defined user needs and intended uses.

The warning letter said that CM had vowed to update its validation requirements by the end of March 2016, but that the company had forwarded no confirmatory documentation. The FDA also said the company had changed the device's packaging from the use of a plastic jar wrapped in a blister package to the pre-filled syringe, which the letter said was not described in the 510(k) filing. The agency added that CM had changed the diameter of the syringe's perforated cap and the color of the syringe plunger, noting that testing for leachables should have been conducted prior to releasing the design into distribution. CM did not respond to contact for comment.