FDA warns premature battery depletion in some ICD and CRT-D devices from St Jude Medical

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fda-streamlines-compassionate-use-application-processThe Food and Drug Administration has recently issued a safety advisory communication regarding premature battery depletion associated with lithium deposits for some implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-D) from St Jude Medical.

The devices addressed in this communication are manufactured before May 2015 and include Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra.

The FDA and St Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. The FDA announced that due to problems associated with lithium deposits in the above mentioned devices, which can form within the battery and create abnormal electrical connections leading to rapid battery failure, patients do not have the normal three-month lead time for device replacement and some batteries have run out within 24 hours of the patient receiving an ERI alert.

The FDA announced that St Jude Medical has initiated a recall and correction of the affected devices and so far 841 out of the 398,740 affected devices sold worldwide were returned for analysis. Two deaths (one in the USA), have been associated with devices that could not provide needed shock therapy due to premature battery depletion. Ten patients (nine in the USA), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion and 37 patients (30 in the USA), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.

The FDA has issued some recommendations for healthcare providers including:

  • 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.
  • Healthcare 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 recognise 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.
  • Enrol patients in Merlin@Home, St Jude Medical’s home monitoring system for these devices, especially those who have difficulty recognising their device’s ERI alerts. For patients already enrolled in Merlin@Home, explain the importance of ongoing home monitoring. Utilise the “Direct Alerts” feature to provide you with an alert notification when a patient’s device has reached ERI.
  • Ensure that the ERI battery alert is ON for all patients.
  • Advise affected patients that an ERI alert triggers a vibratory notification.

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