X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 081 05 11 000
Date submitted: 5/28/2011
Manufacturer:St. Jude Medical Inc
Device Type:Implantable Pulse Generators
Description:Implantable Pulse Generators for Neurostimulation
Medical Device Identifier:Eon Mini (Model 65-3788) and Brio (Model 65-6788) Implantable Pulse Generators
Reason of Field Safety Corrective Action:St. Jude Medical has received reports of inability to communicate or recharge 78 Eon Mini IPGs and 1 Brio IPG. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power which resulted in device replacement. After thorough analysis we determined that weld failures within the internal battery of the IPG caused these reports.
Remedy Action:• For Eon Mini or Brio IPGs not included in the enclosed serial number listing (Attachment A), no actions are necessary. These devices do not contain batteries affected by this issue. • For product within your ununsed inventory included in the serial number listing (Attachment A), please isolate the device(s) for return to St. Jude Medical. A replacement device will be provided at no additional cost to you. • For implanted product included in the serial number (Attachment A), as advised by our Medical Advisory Board: 1. We recommend that you do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. 2. If the duration between recharges becomes significantly shorter or there is a sudden loss of power, contact your St. Jude Medical representative to evaluate if  the recharge burden is within normal operating expectations based on the patient’s programmed parameters  the device is approaching normal end of life expectancy, or  a device replacement is warranted. 3. If device replacement is required due to weld failures within the inner battery, St. Jude Medical will provide a free replacement IPG.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:CE210355EA231
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Manufacturer letter.pdf