SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 105 04 15 000
Date submitted:	4/23/2015

Manufacturer:	Medtronic Inc
Device Type:	Neuromodulation Deep Brain Stimulation (DBS) system extensions
Description:	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.
Remedy Action:	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.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	BCD1F51FB2353
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic Inc.pdf

View History