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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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Reference Number:	mdprc 133 02 14 000
Date submitted:	2/24/2014

Manufacturer:	Medtronic Inc
Device Type:	Spinal Cord Stimulation (SCS) Therapy
Description:	As an intervention for chronic back and/or leg pain, spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies that have failed to manage pain on their own.
Medical Device Identifier:	Details on the affected products is provided in the attachments
Reason of Field Safety Corrective Action:	The manufacturer has identified 14 reports over the last 30 years describing delayed spinal cord compression due to an epidural mass around a Medtronic SCS lead. All patients had neurological deficits and required surgical intervention to remove the mass. Histologically, the epidural masses consisted of reactive tissue (granulomatous and/or fibrous tissue). The reported time to onset of neurological symptoms after lead implant ranged from weeks to 17 years. The severity ranged from muscle weakness to progressive quadriparesis. In several of the cases, only one side of the body was affected. The appearance of neurological symptoms was often preceded by a loss of therapy effect. The reported outcomes in these patients were full recovery (9 reports), permanent impairment (2 reports), and unknown (3 reports). There has not been a report of a patient death associated with this issue.
Remedy Action:	The manufacturer recommends the following: -Medtronic does not recommend prophylactic removal of SCS leads. Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. -If a patient with an SCS lead presents with a new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause. -If an asymptomatic epidural mass is identified, periodic monitoring should be considered.
Athorized Representative/Importer/Distributor:	Gulf Medical Co., (012) 6512828
Report Source:	NCMDR
Source Ref. Number:	5D9D3FC2E82E3
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic Inc.pdf

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