FDA Issues Safety Warning For Premature Battery Depletion Of St. Jude Medical Implanted Defibrillators That Caused Two Deaths Of People
The Food and Drug Administration has issued a safety warning communication on Oct. 11 as published on its website. The safety warning is for premature battery depletion of St. Jude Medical Implanted Defibrillators. The affected products are St. Jude Medical ICD and CRT-D models manufactured before May 2015.
St. Jude Medical has released a medical device advisory, while the FDA is investigating possible cybersecurity errors that could be responsible for the rapid battery depletion of the devices, which are 398,740 affected devices sold worldwide and 841 were returned for analysis. The agency will keep the public informed as new information becomes available.
FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Theoretically this ERI is supposed to inform the user that the battery is dying three months before it really does. However, the affected the battery of affected units just dies without any signs or warnings as some batteries have run out within 24 hours of the patient receiving 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.
The manufacturer cannot always be contacted whenever there is battery depletion. Because of this, the devices - implanted in patients worldwide - cannot always be tracked down and monitored properly, which makes the situation even more difficult.
Impact of the Premature Battery Depletion
2 deaths (1 in the U.S.), 10 patients fainted (9 in the U.S.), 37 patients reported dizziness (30 in the U.S.) have been associated with devices that could not provide needed shock and pacing therapy due to premature battery depletion.
Battery depletion could occur immediately after an ERI and some patients could not detect the alert, but because of the placement of the defibrillators, operations to cut them out of the patients could bring great risks and involve severe complications, which makes close monitoring the best solution to the issue.
The removal of the ICD is not recommended unless strictly necessary, but a consultation of all patients is mandatory.
FDA encourages prompt reporting of adverse events that can help the FDA identify and better understand the risks related to the use of medical devices. You can file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Ultimately, health care providers should individualize the care of their patients based on the patients' medical history, comorbidities and condition.