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 119 02 14 000
Date submitted: 2/20/2014
Manufacturer:Medtronic Inc
Device Type:Activa PC, Activa PC+S, Activa RC, Activa SC, all Restore devices (including SureScan), PrimeADVANCED, PrimeADVANCED SureScan MRI ,and Itrel 4
Description:Spinal Cord Stimulation Neurostimulators
Medical Device Identifier:Activa PC, Activa PC+S, Activa RC, Activa SC, all Restore devices (including SureScan), PrimeADVANCED, PrimeADVANCED SureScan MRI ,and Itrel 4
Reason of Field Safety Corrective Action:This letter is to notify you of corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation (DBS), peripheral nerve stimulation (PNS) and spinal cord stimulation (SCS). More information is provided in the attached letter.
Remedy Action:-If you have patients with cycling enabled or wish to use cycling, use the updated calculations and graphs available online at professional.medtronic.com/cycling to assess the impact of cycling on device longevity. Medtronic will update the product labeling in the second half of 2014.

-Remind your patients to continue to check their battery status. Instructions on how to check battery status can be found in the patient programmer or recharger system manual.

-Pain Stimulation Trialing Only: The cycling feature should not be enabled on the External Neurostimulator (ENS) when estimating device longevity because the resulting longevity estimate for non-rechargeable devices may not provide accurate information.
Athorized Representative/Importer/Distributor:Gulf Medical Co., (012) 6512828
Report Source:NCMDR
Source Ref. Number:89A563E3CE342
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc.pdf