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Arlene Savarese
2 years ago
On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D models. A medical advisory has been released by St. Jude Medical. The FDA is investigating […]
On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D models.
A medical advisory has been released by St. Jude Medical. The FDA is investigating potential cybersecurity errors that may be responsible for the rapid battery depletion of the defibrillators. There are 398,740 affected devices sold worldwide and 841 were returned for examination. The FDA will keep the public apprised of any new information as it becomes available.
St. Jude Medical and the FDA are informing patient, patient-caregivers, and physicians to respond at once to Elective Replacement Indicator (ERI) alerts. This ERI is, in theory, supposed to inform the user that the battery is dying three months before it actually does. The issue is that the affected units die without any warnings or signs. Some batteries have run out within 24 hours of the patient receiving an ERI alert, according to newseveryday.com
Those who are pacemaker dependent are most at risk requiring life-saving shocks to save their lives. If the battery runs out, the ICD or CRT-D will not be able to deliver the life-saving pacing. What makes the situation more difficult is that the manufacturer cannot always be contacted when there is battery depletion.
Due to premature battery depletion 2 deaths occurred, (one in the United States), 10 patients reported fainted, (9 in the U.S.) and 37 patients reported dizziness, (30 in the U.S) when the devices could not provide necessary shock and pacing therapy, reports newseveryday.com.
After an ERI, battery depletion could occur immediately and some patients may not detect the alert. In order to cut the devices out of the patients, the placement of the defibrillators could bring great risks and involve serious complication.