WARNING: St. Jude’s Medical Warns of Potential Premature Battery Depletion In Installed Defibrillators (pacemakers)

By on December 6, 2016

On October 11, 2016, St. Jude’s Medical warned patients with certain of its implantable defibrillator devices (pacemakers) that the batteries may deplete sooner than expected.

According to the FDA, due to problems with the batteries, they may fail sooner than expected and may not give the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert. St. Jude Medical has initiated a recall and correction of the affected devices.

As reported by the FDA, the devices that the warning relates to are the following St. Jude’s Medical ICD and CRT-D models manufactured before May 2015:

  • 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
  • FDA Recommendations for Patients and Caregivers:
  • Contact your physician if you feel a vibratory alert. St. Jude Medical ICD and CRT-D devices are designed to deliver a vibratory alert to you when the battery is nearing its end of life. Immediately contact your physician if you feel the device’s vibratory battery alert. Devices affected by this advisory may reach end of battery life anywhere from within one day to several weeks after the vibratory alert has been delivered. If the device does deliver a vibratory alert due to low battery, it will need to be replaced.
  • Register for home monitoring. St. Jude Medical devices are capable of home monitoring, which can alert your physician to a notification that the battery is approaching end of life. If you do not already use home monitoring for your device, and especially if you have difficulty recognizing your device’s end of battery alerts, you and your physician should consider whether home monitoring is appropriate for you. Please see additional information about the Merlin@Home Monitoring System below.
  • Seek immediate medical attention if you have symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath. These may be signs of a depleted battery.
  • Management of your implanted device and your medical condition must be individualized. You should consult with your health care provider to determine the best course of action.

More information is available directly from the FDA website:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm