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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 074 06 16 000
Date submitted:	6/20/2016

Manufacturer:	Medtronic SA
Device Type:	Temporary Transvenous Pacing Lead System
Description:	Pacing Lead System
Medical Device Identifier:	Model 6416-100, 6416-140 and 6416-200
Reason of Field Safety Corrective Action:	The product is not compliant with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patient’s lead to a possible hazardous voltage.
Remedy Action:	-Please review your inventory for product affected by this issue and perform the following actions: -Immediately identify and quarantine all unused, affected product in your inventory. -Return all unused, affected product in your inventory to Medtronic. Your Medtronic Representative can assist you in the return of affected product as necessary.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	D61B638A83261
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic SA.pdf

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