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FDA Dresses Down St. Jude Medical over Faulty Lithium Defibrillator Batteries

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Washington, DCWhen Chicago’s Abbott Laboratories acquired St. Jude Medical in a $25 billion acquisition this past January, it appears to have inherited a billion-dollars’ worth of headaches that pre-existed before the takeover happened. And now, Abbott is in receipt of a warning letter from the US Food and Drug Administration (FDA) with regard to issues involving battery problems with its St. Jude defibrillators, and security issues with its home monitoring systems.

St. Jude, according to reports, has had problems with other aspects of its defibrillators – implantable devices to help regulate a patient’s heartbeat – prior to the battery problem. Premature insulation failures in recalled St. Jude Medical Riata Defibrillator (ICD) leads have dogged the manufacturer in the past.

Now, according to the Star Tribune (04/12/17), St. Jude and Abbott are continuing to face criticism over problems with defibrillator batteries that have been seen to fail prematurely (and without warning), nullifying dedicated safety measures that allow for a patient and his, or her caregiver to know about the pending failure, providing time to have the failing battery replaced before the looming failure poses a significant risk to the health, indeed the life of the patient.

It was in October of last year that St. Jude issued a voluntary recall of about 400,000 defibrillators due to a rare but serious issue involving the lithium chemistry of its batteries. Deposits of lithium had been found, in rare cases to short-circuit the batteries and cause them to fail suddenly, putting the life and survivability of the patient at significant risk. The failure, according to the Star Tribune, primarily affected older versions of the manufacturer’s Fortify, Unify and Assura line of defibrillators, among others.

The recall was issued in October of last year. However, a month after the recall in November the Star Tribune revealed that St. Jude had continued to ship the suspect devices for more than a year following an update to the battery design aimed at fixing the flaw.

Given allegations of patient deaths in 2014 and 2016 – together with dozens of hospitalizations – the FDA dressed St. Jude down for not doing enough to foster patient care to the best of its ability.

“We have reviewed your response and conclude that it is not adequate,” said the FDA warning letter to St. Jude. “You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.

“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 warning letter, issued by the FDA this past April, says. The communique also noted that a patient death in 2014 wasn’t provided to medical advisers assessing the risk at the time. It should have.

The Star Tribune notes that St. Jude continued to ship the allegedly flawed St. Jude Medical defibrillators with the faulty batteries until the recall was issued in October, 2016. However, it was noted that 10 units were shipped after the recall was issued, and seven devices were actually implanted in patients after the St. Jude Medical recall was announced.

The FDA also took St. Jude to task for not taking adequate steps to ensure its Merlin@home monitoring devices were protected from cyber hacking, an accusation made last year by the investment research firm Muddy Waters Capital.

St. Jude and Abbott issued a statement suggesting that patient safety was the firm’s primary responsibility.

To date, 841 devices were returned for analysis due to premature battery depletion. In addition to the two reported deaths, 10 people have reported fainting and 37 have reported dizziness from devices that could not provide adequate pacing therapy due to battery depletion. The recalled St. Jude devices were manufactured before May 2015 and include the following ICD and CRT-D models:

Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify Assura ST VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Fortify Assura ST DR
Unify
Unify Quadra
Unify Assura
Quadra Assura
Quadra Assura MP

The FDA warning letter was issued April 12.

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