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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 096 12 15 000
Date submitted: 12/23/2015
Manufacturer:Cyberonics Inc
Device Type:Model 106 AspireSR® VNS Therapy® generator
Description:VNS Therapy
Medical Device Identifier:Error message displayed upon interrogation of M106 Generator after event
Reason of Field Safety Corrective Action:Due to unintended behavior in the Model 106 AspireSR generator software, the generator can stop delivering stimulation unexpectedly. This event can only occur when a rare combination of circumstances are present, one of which is when the AutoStim Output Current is programmed greater than or equal to the Magnet Output Current. Stimulation can be reinitiated at the next office visit by programming stimulation output current on.
Remedy Action:This issue is preventable by following programming recommendations provided in Cyberonics’ Physician Training Material (see Figure 2, VNS Therapy Dosing Guidelines). If a Model 106 generator is programmed with the Magnet Output Current greater than the AutoStim Output Current, this condition will not occur. No action is needed for those patients already programmed in this manner.

Note: For AspireSR Model 106 generators, programming output current allows 0.125 mA increments up to 2.0 mA and 0.250 mA increments from 2.0-3.5 mA.

If it is identified that a patient’s generator has been disabled due to this condition, please contact Europe Clinical Technical Support at +32-2-790-27-73 to report the event. The generator output currents for Normal, Magnet, and AutoStim should be programmed back on (i.e., greater than 0 mA) to resume therapy, following the programming recommendations presented in Figure 2 to prevent recurrence of the issue.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:849A8E99F4339
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Cyberonics Inc.pdf