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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 105 04 15 000
Neuromodulation Deep Brain Stimulation (DBS) system extensions
Deep Brain Stimulation Therapy
Medical Device Identifier:
Models 37085 and 37086
Reason of Field Safety Corrective Action:
This FSN communicates issues related to high impedances, and reinforces device labeling specific to the handling of extensions and system integrity checking during implant procedures.
Current labeling for the handling of the system during implant is described within the implant manual distributed with each device.
To minimize the potential for a conductor wire fracture, please follow the instructions defined within the Neurostimulator implant manual related to extension implantation, specifically to ensure that the extension is not bent sharply or kinked. Check electrode impedances for open circuits, prior to pocket closure, which could indicate a potential conductor fracture. An example of the implant manual sections, relevant to these recommendations, is shown below from the Activa® PC Model 37601 Implant manual.
Gulf Medical Co.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.