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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 002 04 12 000
Date submitted: 4/3/2012
Manufacturer:St. Jude Medical Inc.
Device Type:Implants, active, stimulators, neuro, BRIO IPG (MODEL 6788)
Description:Implants, active, stimulators, neuro, Implantable Pulse Generators (Spinal Cord Stimulator) & (Deep Brain Stimulator).
Medical Device Identifier:MODEL 6788
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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:A76FF00CC52D7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: St. Jude Medical Inc..pdf