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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 050 01 16 000
Date submitted: 1/13/2016
Manufacturer:Medtronic SA
Device Type:Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead
Description:Neural - Tissue Electrical Stimulation
Medical Device Identifier:Model 39565 and 39286
Reason of Field Safety Corrective Action:The purpose of this letter is to notify you that labeling is being updated to clarify that the Specify 5-6-5 and 2x8 surgical leads are not intended for interoperative trial evaluation use (i.e., trialing/screening outside of the operating room with an external neurostimulator).
Remedy Action: Ensure you and your staff are aware that the Specify 5-6-5 and 2x8 surgical leads are not intended for interoperative trial evaluation use (i.e., trialing/screening outside of the operating room with an external neurostimulator). Please share this notification with others in your organization as appropriate and retain this letter for your records.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:9E0B99BE22222
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf