FDA approves software update for faulty defibrillator
The U.S. Food and Drug Administration (FDA) approved a software update from Medtronic that will help detect fractures in the company’s Sprint Fidelis cardiac defibrillator lead. The software will alert both patients and physicians of a possible fracture in the defibrillator lead. Earlier intervention in the event of such a fracture will help patients avert the serious complications that can arise.
The new software update, known as the Lead Integrity Alert, will sound an audible alert should it detect signals that indicate a fracture in the lead. The alert will sound repeatedly every four hours until a doctor can reset the defibrillator. The software update also revises the device’s original settings so that it has more time to discern a lead fracture from an abnormal heart rhythm. This change will likely reduce the number of times the defibrillator inappropriately shocks the patient.
As we have reported earlier, a Texas man filed a lawsuit against Medtronic, claiming that his cardioverter defibrillator containing a Sprint Fidelis lead gave him several unexpected and unnecessary shocks, causing excruciating pain and emotional stress.
To ensure that the software update fulfills its purpose and protects patients as it was designed to do, Medtronic will actively monitor the update during actual use.
According to Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, Medtronic’s software update “will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock. While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”
Implantable defibrillators deliver a pulse of energy through a thin electronic wire (the lead) whenever it detects a rhythmic abnormality in the heart. The shock sets the heart back into a normal rhythm.
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