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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 079 03 17 001
Date submitted: 9/3/2017
Manufacturer:Medtronic SA
Device Type:DBS Lead Depth Stop
Description:Stimulators, Electrical, Brain
Medical Device Identifier:Models 3387, 3389 and 3391 DBS Lead Kits
Reason of Field Safety Corrective Action:Medtronic has received three (3) complaints from physicians reporting that the DBS depth stop did not adequately secure to the lead. In two of the three complaints received, this resulted in initial DBS lead placement beyond the intended target, which was identified via intraoperative imaging and corrected with no report of patient harm. In the third instance, the issue was identified prior to lead insertion. (See attached FSN)
Remedy Action:If your surgical procedure involves the use of the Medtronic DBS depth stop, Medtronic recommends the following:
• For implanted product: If product has already been implanted, no action is needed since lead placement at the intended target location is expected to have been confirmed through intraoperative test stimulation, imaging, and/or therapy effectiveness.
• For product not yet implanted: If you suspect that the depth stop is not tightening adequately onto the lead, do not use, and complete the procedure using a depth stop from another Medtronic DBS lead kit. As stated in the DBS lead implant manual, Medtronic recommends that you check the stimulation effect during the implant procedure and use imaging techniques to confirm lead placement.
Medtronic has implemented manufacturing process changes to address this issue. When sufficient inventory of replacement product becomes available, expected within 2-3 months, Medtronic will retrieve any unused affected products.
…………………..

NCMDR Update action:
Work with your Medtronic representative to return any unused DBS lead kits listed in this letter. Your Medtronic representative can assist you with ordering replacement product.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:1EA8E30955207, 18829116B41F5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf