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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 098 06 16 000
Date submitted: 6/26/2016
Manufacturer:Medtronic SA
Device Type:Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors
Description:Deep Brain Stimulation
Medical Device Identifier:Models 64001 and 64002
Reason of Field Safety Corrective Action:Medtronic has identified sixteen (16) DBS pocket adaptors that were returned for high impedance measurements and where subsequent Medtronic analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block.
Remedy Action:Current labeling for the handling of the system during implant is described within the implant manuals. To minimize the potential for a conductor wire fracture, please follow the instructions defined within the DBS Pocket Adaptor Implant Manual as shown in attachment, to ensure that the adaptor wire is not bent sharply or kinked at the time of implant. The full implant manual can be found in product packaging.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:2A978441481CE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic SA.pdf