FDA warns Abbott on St. Jude Medical plant in California

The FDA yesterday issued another warning letter about a St. Jude Medical (NYSE:STJ) plant in California, now owned by Abbott (NYSE:ABT), that makes cardiac rhythm management products.

It’s at least the 2nd time the federal safety watchdog has flagged the plant in Sylmar, which makes defibrillators and the Merlin home cardiac monitor. In 2012 the FDA slapped St. Jude with a warning letter over problems with the manufacture of its Durata defibrillator leads; that letter was closed out in July 2014. Abbott paid $25 million earlier this year to acquire St. Jude.

The FDA said inspections at the plant in February turned up issues with the implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators made in Sylmar, stemming from battery problems that surfaced last year. St. Jude warned in October 2016 that there’s a risk that the lithium-based batteries used in its ICDs and CRT-Ds could form “lithium clusters” during high-voltage charging; the clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy. There were 841 premature depletion incidents among 398,470 devices (roughly 0.21%), including 2 deaths “associated with the loss of defibrillation therapy as a result of premature battery depletion,” St. Jude said.

The company failed to properly address the lithium bridging issue, sold some affected devices after the problem became known and underestimated the severity of the problem, the FDA said in yesterday’s letter.

The agency also flagged St. Jude for its lack of progress in demonstrating that it’s eliminated cybersecurity vulnerabilities in theMerlin@home software, after a short-seller last year revealed that hackers could access the devices.

An Abbott spokesman told MassDevice.com via email this morning that the company is working to address the issues named in the warning letter.

“At Abbott, patient safety comes first. We have a strong history and commitment to product safety and quality, as demonstrated by our operations across the company. Abbott acquired St. Jude Medical in January 2017; the FDA inspection of the Sylmar facility, formerly run by St. Jude Medical, began on February 7; and we responded to the 483 observations on March 13, describing the corrective actions we are implementing. 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,” he said.

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