FDA Addresses St. Jude Medical About Faulty Lithium Defibrillator Batteries

St. Jude Medical (subsidiary of Abbott Laboratories) received a warning letter from the US Food and Drug Administration (FDA) this week about issues involving its defibrillator batteries that have been seen to fail prematurely and without warning. This is a danger that poses a significant risk to the health and lives of patients. To date, there have been two reports of deaths, 10 reports of fainting, and 37 reports of dizziness from devices that could not provide adequate pacing therapy due to battery depletion.  Public reports indicate that a total of 841 devices have been returned for analysis. The FDA warning letter to St. Jude said, “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.”

If you or a loved one suffered complications after receiving a St. Jude Medical Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator, please contact us at 888-984-7988 for a confidential evaluation of your potential claim.

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