Rockville, MD - The US FDA has approved a software upgrade from Medtronic designed to warn patients of a possible fracture in Sprint Fidelis leads connected to its implantable devices with defibrillator capability [1,2].

Devices with the new feature, the Lead Integrity Alert (LIA), will sound a warning when it detects signals that could be associated with lead fracture and repeat it every four hours until the patient's physician addresses the problem, the agency observed. The device will also self-adjust to give it more time to distinguish between signals caused by lead problems and those indicating a shockable arrhythmia, potentially cutting down on inappropriate discharges.

Medtronic issued an advisory for its popular Sprint Fidelis leads in October 2007, citing a modest rise in lead's fracture rate relative to the performance of its Quattro line of leads; the increase didn't meet statistical significance, but the company expected that would eventually change.

As reported by heartwire at the time, the company said Sprint Fidelis leads had failed at a known rate of 2.3% after 30 months on the market. On August 29, 2008, Medtronic posted on its website [3] that the failure rate had increased by month 39 to 3.5% as tallied by the company's CareLink system and to 4.8% according to its System Longevity Study, which tracks patients implanted with Medtronic leads [4].

According a Medtronic statement, the LIA upgrade will increase the proportion of patients who will get at least three days of advance warning before a Sprint Fidelis fracture could elicit an inappropriate shock.