FDA Safety Communication - Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices

PUBLISHED: Oct 11, 2016
Source: Food and Drug Administration

The US Food and Drug Administration (FDA) has issued a Safety Communication alerting health care professionals that St. Jude Medical ICD and CRT-D batteries may fail earlier than expected.

The FDA and St. Jude Medical are advising patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not have 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.

Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure. St. Jude Medical has 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 patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.

To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.

  • 2 deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
  • 10 patients (9 in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion.
  • 37 patients (30 in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

Devices may be programmed to deliver a vibratory patient alert when the battery has reached ERI. In addition, St. Jude Medical’s home monitoring system may be used to monitor battery status and provide health care provider notifications. Due to the low frequency of device failure, these are likely appropriate mitigations for most patients, as patients could be at greater risk of complications from the surgical procedure required to replace the device.

Recommendations for Health Care Providers:

  • Do not implant unused affected devices. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.
  • 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 also followed with remote monitoring.
  • Immediately replace the device at the time of an ERI alert. Currently, there is not a factor, method, or test to identify when devices with this form of premature battery depletion are approaching ERI, or to accurately predict remaining battery life once ERI appears.
  • Pacemaker-dependent patients with a device that has reached ERI should be treated as a medical emergency.
  • 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 ERI, as the rate of complications following replacement surgery are higher than those associated with premature battery depletion. However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.
  • Enroll patients 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 already enrolled in Merlin@Home, explain the importance of ongoing home monitoring.
  • Ensure that the ERI battery alert is ON for all patients. Review the most recent “Programmed Parameters” printout.
  • Review the “Trigger Alerts When” section, and ensure that the “Device at ERI” parameter is “On” for both the “Show on FastPath” and “Notify Patient” selections.
  • If the “Device at ERI” alert is “Off”, the patient should be seen promptly to program this parameter to“On”.
  • Advise affected patients that an ERI alert triggers a vibratory notification, and perform the following procedures at each scheduled office visit:
  • Interrogate the patient’s device to determine if an ERI alert has been triggered. Premature battery depletion can be identified by health care providers through home monitoring showing ERI or more advanced battery depletion.
  • Perform a patient notifier test to confirm that the patient feels and recognizes the vibratory alert.
  • Patients who cannot feel the vibratory alert may experience loss of battery and/or loss of device function without their awareness.
  • Advise the patient to contact your office promptly should they feel a vibratory alert. An in-office evaluation should be performed to determine the reason for the alert as other non-critical events can also trigger a vibratory alert.

For additional information, read the full FDA Safety Communication, link is provided below.

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