SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 104 05 16 000
Date submitted:	5/23/2016

Manufacturer:	Medtronic Advanced Energy, LLC
Device Type:	DBS Tunneling Procedure
Description:	Deep Brain Stimulation
Medical Device Identifier:	Models 7483, 37086 and 37087
Reason of Field Safety Corrective Action:	Medtronic’s post marketing surveillance for DBS therapy has identified the following serious events or injuries associated with tunneling that are not presented in the current DBS labeling. The following events are associated with the DBS implant and tunneling the extension from the lead to the INS: • Cases of spinal accessory nerve injury • Severe bleeding or vascular injury • An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision • Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed
Remedy Action:	During the DBS implant, use caution while tunneling the extension from the lead to the INS to avoid tunneling too deeply or superficially because serious injury may occur.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	7B7ED873D2316
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic.pdf

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