Defibrillator Lead Fractures Detection Software Approved by FDA

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Defibrillator Lead Fractures Detection Software Approved by FDA

September 5th, 2008 laurie

Nearly a year after Medtronic’s Sprint Fidelis Leads were recalled for shocking heart patients to death, the FDA announced today the approval of a software update from Medtronic that will help detect fractures of the company’s Sprint Fidelis cardiac defibrillator lead. The new software package’s purpose is to alert both patients and physicians of a potential lead fracture and hopefully enable early intervention and lower the risk of serious complications.

The Sprint Fidelis lead, the subject of an October 2007 Medtronic recall, was prone to fracture in a small number of patients, potentially causing the lead to deliver unnecessary shocks or not operate at all. Most of the patients with the Sprint Fidelis lead still have the device implanted because of the surgical risk 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.

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