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FDA warns Abbott on heart device battery, cybersecurity issues

by Thomas Dworetzky , Contributing Reporter
The FDA has issued a new warning letter to St. Jude Medical focusing on problems involving batteries in its implantable defibrillators and the potential hacking vulnerability of its in-home monitoring gear.

“We have reviewed your response and conclude that it is not adequate," the FDA said in its letter.

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Spokesman Jonathon Hamilton of Abbott Laboratories, which acquired St. Jude in January, responded to the Star Tribune in Minneapolis about these concerns, stating, “We take these matters seriously, continue to make progress on our corrective actions, will closely review FDA's warning letter, and are committed to fully addressing FDA's concerns."

The $25 billion acquisition deal added medical devices, diagnostics, nutritionals and branded generic pharmaceuticals to Abbott's roster of products.

"We continue to deliberately shape our business for long-term success by securing leadership positions in attractive markets and focusing on customer needs," said Abbott's chairman and CEO, Miles D. White, in a statement. He noted that adding St. Jude “creates one of the broadest medical device portfolios in the world.”

Overall, analysts appear to think the problems should not impact the company significantly.

The Chicago Tribune reported that Stifel analyst Rick Wise wrote that the letter might cause “lingering concern” but that the issues are “fixable and resolvable given Abbott's considerable manufacturing expertise and some time."

Over at Morningstar, analyst Debbie Wang, did note that it could complicate future FDA approvals. For example, Abbott is in the process of getting an MR-safe implantable defibrillator okayed.

"That could be held hostage by the FDA until the company has sufficiently addressed all these concerns," Wang said, according to the paper.

Spokesman Hamilton stated that there is an evaluation underway to see “how this may impact anticipated product approvals" from the facility that is the subject of the agency letter.

On the battery problems, which the Star Tribune advised affected older versions of its Fortify, Unify and Assura defibrillators, agency inspectors wrote, “FDA reviewed 42 of your firm’s Product Analysis Reports, produced between 2011 and 2014. These reports showed, in instances when your supplier’s analysis provided evidence that lithium cluster bridging had prematurely drained the battery, your firm repeatedly concluded that the cause of premature depletion of Greatbatch QHR2850 batteries 'could not be determined.' Your firm later categorized these as 'unconfirmed' lithium bridges.”
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