SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 038 08 15 000
Date submitted:	8/11/2015

Manufacturer:	Medtronic Inc
Device Type:	Activa® PC, Activa® SC, Activa® RC, Activa® PC+S, Kinetra®, and Soletra®
Description:	Neuromodulation Stimulation
Medical Device Identifier:	all
Reason of Field Safety Corrective Action:	The purpose of this letter is to notify you of information that is being added to the Warnings and Adverse Events sections of Medtronic’s Deep Brain Stimulation (DBS) labeling. ( You can find these information in attachment )
Remedy Action:	Ensure you are aware of the warnings and adverse events associated with DBS Therapy covered in this notification. Please retain this notification for your records until the updated warnings and adverse events are integrated into the labeling for DBS Therapy. This information is being provided to help you with the management of your patients and give you visibility into the upcoming changes for labeling.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	50EECC49862D9
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic Inc.pdf

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