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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 052 11 17 000
Date submitted: 11/16/2017
Manufacturer:Medtronic SA
Device Type:SynchroMed II Implantable Drug Infusion Pump.
Description:Infusion Pump.
Medical Device Identifier:Pump Identification: in Europe, Middle East, Africa, Latin America and India any pump with a Use By Date on or before 2018-12-31 was manufactured prior to design change. An image of the Shelf Box Side Label of the SynchroMed II is shown in attached
Reason of Field Safety Corrective Action:The purpose of this letter is to advise you that Medtronic has received approval to implement a design change to the SynchroMed II implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy.
Remedy Action:Medtronic recommends the SynchroMed II infusion system be used according to approved product labeling. Reliability for SynchroMed II pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication. All SynchroMed II pumps are now manufactured with the new design change, although there are limited quantities of these new devices available. To ensure your patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. Once there is sufficient inventory of the pumps with the new design, we will no longer distribute pumps manufactured prior to this change.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:4DDE0753DE263
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf