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FDA: St. Jude Defibrillator Batteries Can Deplete in 24 Hrs

October 11, 2016 — St. Jude Medical Inc. is warning that batteries on some implantable defibrillators can deplete within 24 hours, which could cause patient injuries or death if it fails to deliver a life-saving shock.

Two people died after their defibrillators failed due to the drained battery, while 47 other patients reported dizziness or fainting.

Premature battery depletion has been seen in less than 1% of the nearly 400,000 devices sold worldwide, but the problem may be under-reported.

Patients should respond immediately to the device’s alert indicating low battery. They do not have the normal 3-months to replace the batteries. Full battery drainage can occur within one day to a few weeks, according to the FDA.

The FDA issued a Safety Communication about the problem on ICD and CRT-D models manufactured before May 2015, including:

  • 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

Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. In some cases, lithium accumulates and creates “lithium clusters” inside the battery that creates a short-circuit and rapidly drains the battery.

The problem was described in the journal Heart Rhythm in 2014. Researchers at Duke University identified 39 cases of premature battery depletion associated with the St. Jude Fortify and Unify ICDs between January 2010 and November 2013.

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