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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 047 01 15 000
Date submitted: 1/12/2015
Manufacturer:Medtronic Inc
Device Type:InterStim, InterStim II, Itrel3 and Enterra
Description:Neurostimulation devices
Medical Device Identifier:InterStim (Model 3023), InterStim II (Model 3058), Itrel 3 (Model 7425), and Enterra (Model 3116)
Reason of Field Safety Corrective Action:This letter is to notify you of updates to labeling related to the cycling feature in some Neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation.
Remedy Action:References to the use of cycling for improved battery longevity, when compared to continuous mode, are not accurate for every combination of programmable parameters. If cycling is being used solely to improve device battery longevity, the information in attachment should be considered.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:E746CF66702D2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc.pdf