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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 120 02 13 001
Date submitted: 6/22/2013
Manufacturer:Medtronic Inc
Device Type:Lead Kits, Deep Brain Stimulation (DBS™) Lead Kits
Description:Lead Kits, Brain Stimulation
Medical Device Identifier:Models 3387, 3387S, 3389, 3389S, 3391, 3391S

BfArM update code :

In June 2013 Medtronic began distributing lead kits manufactured after the process changes. lead kits manufactured after the process changes can be identified by the UPN number located on the shelf box side label ( see attached) and on the device registration stickers. A document identifying new product UPN's and their location on the package is attached. Please note that the UPN is the only way to identify the corrected product.(please see attached)
Reason of Field Safety Corrective Action: DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead.
Remedy Action: Medtronic is working on corrective actions to reduce the occurrence of setscrew connector block twisting which may result in lead damage. Until these corrective actions are in place, follow the modified instructions as attached.
Athorized Representative/Importer/Distributor:Gulf Medical Co, Jeddah, (02)6512828
Report Source:NCMDR
Source Ref. Number:BD598F6737243
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf