FDA Issues Alert for Pacemakers That Fail Without Warning

For What Type of Implant did the FDA Issue a Warning?

  1. Breast Implant
  2. Pacemaker
  3. Gastric Bypass
  4. Brain Implant

Answer: Pacemaker

St. Jude Medical reports that two deaths have occurred due to batteries in heart defibrillators failing much earlier than expected, and the FDA and St. Jude have issued a warning for users of about 400,00 devices.

The batteries in these devices appear to fail without advanced warning, but an Elective Replacement Indicator (ERI) is supposed to alert the patient months before any replacement is warranted.

“If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death,” the FDA said.

Doctors have not been requested to remove the devices from patients immediately, but they should communicate with them to make sure their devices are functioning properly.

Affected devices include the St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device.

“The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.”

“St. Jude Medical recently announced a global medical device advisory for a subset of our company’s Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. This advisory was implemented after an analysis found that some devices manufactured prior to May 23, 2015 contain batteries which may run out of energy earlier than expected. This is termed: ‘premature battery depletion’.”

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