FDA Warning: St. Jude Defibrillators May Fail Earlier Than Expected

Alert affects devices made before May 2015

The FDA and St. Jude Medical are alerting physicians, patients, and caregivers to respond immediately to elective replacement indicator (ERI) alerts on implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) from St. Jude. Because of problems with the batteries, patients do not have the normal three-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.

The manufacturer reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as lithium clusters, can form within a battery and create abnormal electrical connections leading to rapid battery failure.

Premature battery depletion due to lithium clusters has been observed only in St. Jude devices manufactured before May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.

Battery depletion may not always be reported to the manufacturer; therefore, the true number of devices with premature battery depletion due to lithium clusters is not known. At this time, 349,852 affected devices remain actively implanted worldwide.

The FDA will continue to monitor affected St. Jude Medical ICD and CRT-D devices for adverse events related to premature battery depletion.

Meanwhile, the FDA recommends that health care professionals take the following steps:

  • Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.
  • Immediately replace the device at the time of an ERI alert. Currently, there are no factors, methods, or tests to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once an ERI appears.
  • Do not implant unused affected devices.
  • Communicate with all patients who have an affected device that their device has a battery that may run out earlier than expected. Consider giving patients the Dear Patient letter provided by St. Jude Medical.
  • Continue to conduct follow-up on patients with affected devices using in-office visits in addition to remote monitoring once they have been notified of the battery issue. Increased in-office surveillance is not necessary for patients who are followed with remote monitoring.
  • Health care providers should consider whether elective device replacement is warranted for their pacemaker-dependent patients. Ultimately, health care providers should individualize the care of their patients based on the patients’ medical history, comorbidities, and condition.
  • Most patients will not require prophylactic device replacement prior to an ERI, as the rate of complications following replacement surgery is higher than that associated with premature battery depletion. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced that it will provide a replacement device at no cost.
  • Patients should be enrolled in Merlin@Home, St. Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognizing their device’s ERI alerts. For patients who have already enrolled in Merlin@Home, health care professionals should explain the importance of ongoing home monitoring. The “direct alerts” feature can be used to provide physicians with an alert notification when a patient’s device has reached ERI. If a home monitor is ordered for a patient with an affected device, St. Jude Medical will cover the cost of the home monitor.
  • Ensure that the ERI battery alert is ON for all patients. Review the most recent “programmed parameters” printout.

Source: FDA; October 11, 2016.