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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 033 04 11 000
Date submitted: 4/12/2011
Manufacturer:Medtronic Inc
Device Type:Sprint Fidelis® Lead, Defibrillator
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Gulf Medical Co. Jeddah (02) 6512828
Report Source:NCMDR
Source Ref. Number:7845E4788F2A8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Manufacturer letter.pdf