Alert System for Defibrillators Introduced by Medtronic
Medtronic introduced a new device safeguard product, Lead Integrity Alert (LIA) software. The solution received approval from the FDA and also has the CE mark and is described in the company’s press release.
The system was particularly designed to support patients who have Medtronic defibrillator or defibrillator leads implanted. When leads are fractured or there is potential for a fracture, an audible alert is issued by the system. Fractures can result in unncessary shocking.
Features of the LIA system include improved sensing capabilities that detect lead fractures sooner. This feature increases the time between detection of lead fracture and potential shock delivery.
The company’s data indicates that over three-quarters of patients will receive warning of a potential fracture at least three days before it occurred. Without the LIA, more than half the patients would receive notice of two days or less. When patients hear the alert, they should contact their physician.
The tool was created to improve patient safety by allowing surveillance assessment of lead performance. An additional advantage of the system is improved safety and increased patient wellbeing. The system is being integrated into all of the company’s ICDs and CRT-Ds as a software upgrade.
September 8, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Quality, Safety, Errors, Cardiology