At least seven patients had recalled St. Jude defibrillators implanted in their bodies, after it was discovered that the devices contain defective batteries that may fail suddenly, according to federal regulators.
St. Jude Medical and Abbott Laboratories received an FDA warning letter on April 12, indicating that 10 defibrillators were shipped out after they were recalled late last year, with seven of the devices surgically implanted in patients.
The warning also notes that the company underestimated the rate of defibrillator battery failures in the devices, because it did not factor in a number of unconfirmed reports of battery depletion which it had received.
On October 24, 2016, the FDA announced a St. Jude Implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) recall, affecting some Fortify, Unify and Assura heart implants. The recall came after it was determined that the devices could experience rapid battery failure.
At least two deaths and dozens of adverse event reports have been linked to the St. Jude battery problem.
The FDA warning letter indicates that St. Jude, which was acquired by Abbott in January, had received reports regarding the battery failures since at least 2011. The FDA reviewed 42 such reports received 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,” the letter states. “By basing your firm’s risk evaluation on ‘confirmed’ cases and not considering the potential for ‘unconfirmed’ cases to have been shorts, your firm underestimated the occurrence of the hazardous situation.”
The FDA warned that the company did not confirm that it had conducted all the legally required corrective and preventative actions, and did not confirm that it had adequately verified the corrective actions it took in response to those problems and cybersecurity vulnerabilities, among numerous other problems mentioned in the letter.
The company has 15 days to respond to the letter, in which it must explain the steps it has taken to correct the problems, and describe how it will prevent such problems in the future.