Valve Magnet Reverse Polarity for Medtronic Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal, and excludes StrataMR™)
Healthcare professional
Medical devices
21 February 2017
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Medtronic International Ltd would like to inform healthcare professionals of an additional warning regarding a potential condition related to the Strata Valve that can lead to inaccurate pressure level reading on the Strata™ Indicator Tool or StrataVarius™ system. The condition occurs when the magnet inside the valve becomes reverse polarised, which may occur 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. If difficulty is experienced adjusting or reading the valve setting, radiographic setting confirmation should be considered. The Instructions For Use of the affected products will be updated with the relevant warnings. Please refer to letter for details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
