Almost a Year After Sprint Fidelis Recall, Medtronic Unveils Technology to Detect Defibrillator Lead FracturesSep 5, 2008 | Parker Waichman LLP
Medtronic has received approval from federal regulators for a software update to its implantable defibrillators that will help detect fractures (breaks) in their lead wires. The Food & Drug Administration (FDA) approval of the software update comes nearly one year after Medtronic recalled its Sprint Fidelis defibrillator lead wires because of their high fracture rate.
A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.
Medtronic suspended sales of the Sprint Fidelis Leads last October after receiving reports of 5 fatalities linked to lead fractures. The Sprint Fidelis had been fracturing at a rate of 2.3% over a 30-month period, more than twice that of an older Medtronic lead, called the Sprint Quattro.
By the time Medtronic issued the recall, the lead had green implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide. The FDA says most of the patients with the Sprint Fidelis lead still have the device implanted because of the danger associated with removal, and are being monitored by their health-care providers for potential fracture.
Medtronic's new software feature, called the Lead Integrity Alert, issues an audible alert once it detects signals that could indicate that the lead has fractured, and then repeats the alert every four hours until a physician can reset the defibrillator. In addition to an audible alert, the new software also modifies the device settings so the defibrillator has more time to consider whether a lead fracture or an abnormal heart rhythm has occurred, a change intended to reduce the number of inappropriate defibrillator shocks. The physician can download the Lead Integrity Alert feature onto Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.
“This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said in a press release. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”
The FDA press release said that Medtronic has agreed to actively monitor the performance of the new software feature in actual use, which will allow both the company and the agency to ensure that the device is protecting patients as intended.