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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 033 04 11 000
Sprint Fidelis® Lead, Defibrillator
This lead is designed for pacing, sensing, cardioversion and defibrillation therapies.
Medical Device Identifier:
Sprint Fidelis Lead Patient Models 6949, 6948, 6931, 6930.
Reason of Field Safety Corrective Action:
The potential for Fidelis pace-sense conductor fractures.
Medtronic recommends implanting a new high voltage lead, with or without extraction of the Fidelis lead. It is no longer a recommended option to implant a pace-sense lead while maintaining use of the Fidelis high voltage conductors after a Fidelis pace-sense conductor fracture has occurred.
Gulf Medical Co. Jeddah (02) 6512828
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.