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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 139 01 17 000
Date submitted: 1/31/2017
Manufacturer:Medtronic SA
Device Type:Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) Valve Magnet Reverse Polarity (Excludes StrataMR™)
Description:Adjustable pressure valves
Medical Device Identifier:Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) Valve Magnet Reverse Polarity (Excludes StrataMR™)
Reason of Field Safety Corrective Action:The products identified above may have a rare condition related to the Strata Valve that can lead to an inaccurate pressure level (PL) reading on the Strata™ Indicator Tool or StrataVarius™ system. The condition occurs when the magnet inside the valve becomes reverse polarized*, which may occur only if a patient has been exposed to 3T MRI magnetic field or greater and biological debris is present to an extent that the valve magnet adjustment mechanism is impacted.
Remedy Action:Medtronic will notify customers associated with the affected devices of the potential issue and inform them labelling will be updated in accordance with the information provided in the FSN.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:97AAE984C9377
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf