The Food and Drug Administration has issued a warning concerning premature battery depletion of defibrillators, which has caused the death of two people. The affected heart products are Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillator, manufactured by St. Jude Medical 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 estimated to be about 400,000 units worldwide.
"We have asked physicians to contact their patients with information about this advisory. Device replacement is not recommended unless the physician determines otherwise," St. Jude Medical said. According to the manufacturer's statement, the safety of patients represents the primary concern, along with closely monitoring every possible outcome of their activity.
Theoretically, the devices have an Elective Replacement Indicator that 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.
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.
"The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent," the FDA said.
Should the batteries die out, there will be no more life-saving shocks or pacing that stop fast heart beats suffered by people with heart rhythm problems or heart failure. This is why patients and caregivers are advised to immediately contact their physician in case of a vibratory alert.
The lithium clusters that formed inside the batteries creates a faulty connection that leads to fast battery drainage. According to a St. Jude, should the device fail to work in case of electric malfunctions, it will be replaced at no costs.
The manufacturer cannot always be contacted whenever there is a 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.