The US Food and Drug Administration (FDA) has issued a statement that healthcare professionals and their patients with either implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured by St. Jude Medical should immediately respond to Elective Replacement Indicator (ERI) alerts.
St. Jude Medical has initiated a recall and correction of these devices on account of battery depletion due to lithium clusters.
When a patient normally receives an ERI alert, there is a 3-month lead time for device replacement, but some of these batteries have depleted within 24 hours of an alert. If a battery runs out, the ICD or CRT-D will not be able to deliver life-saving pacing or shocks which could lead to patient death.
Because battery depletion is not always reported to the manufacturer, the exact number of defective devices is unknown. The FDA reported that 349,852 ICDs and CRT-Ds remain actively implanted worldwide.
The agency noted that it would continue to monitor St. Jude Medical devices for any adverse events related to the premature battery depletion or “cybersecurity vulnerabilities.”
Current recommendations for healthcare professionals include the following:
- Do not implant unused affected devices.
- Inform patients who have an affected device that their battery may run out earlier than expected.
- Ensure that the ERI battery alert is on for all patients and review the most recent “Programmed Parameters” printout.
- Follow up with patients with in-office visits in addition to remote monitoring.
- At the time of an ERI alert, immediately replace the device.
- When patients who are pacemaker-dependent receive an ERI alert, it should be treated as a medical emergency.
- Individualize patient care based on their medical history, comorbidities, and conditions.
- Enroll patients in St. Jude’s Medical home monitoring system for these devices at [email protected]
For more information, visit the FDA MedWatch Report.
Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St. Jude Medical: FDA safety communication – batteries may fail earlier than expected [news release]. Silver Spring, MD: US Food and Drug Administration; October 11, 2016. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts
/ucm524706.htm. Accessed October 12, 2016.