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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 002 04 12 000
St. Jude Medical Inc.
Implants, active, stimulators, neuro, BRIO IPG (MODEL 6788)
Implants, active, stimulators, neuro, Implantable Pulse Generators (Spinal Cord Stimulator) & (Deep Brain Stimulator).
Medical Device Identifier:
Reason of Field Safety Corrective Action:
St. Jude Medical received reports of therapy degradation associated with a small number of Brio IPGs at a very limited number of hospitals. An analysis of returned devices found that fluid had intruded into the IPG header assembly leading to diminished or loss of therapy. Septum damage, which can occur during implant, was found in a majority of the explanted devices and can contribute to fluid intrusion into the IPG header assembly. We are taking a proactive approach by issuing a voluntarily field corrective action for the Brio IPG and implementing improvements to the product.
St. Jude Medical is informing physicians to immediately discontinue the implantation of the Brio IPG and isolate the device(s) for return to St. Jude Medical.
Al-Faisaliah Medical System, Riyadh, (01) 2119948
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
St. Jude Medical Inc..pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.