StrataMR Adjustable Pressure Valve
Manage hydrocephalus with a shunt intended to maintain its performance level setting under MRI exposure when scanned in accordance with the MR conditions in the labeling.
Medtronic is conducting a voluntary recall of the StrataMR valve due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.
Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting, and lethargy. If left untreated, under-drainage can potentially lead to coma and death. Patients and their caregivers should monitor the patient's condition and if they find they are experiencing any of the aforementioned symptoms, they should consult the physician who implanted the StrataMR valve.
Medtronic requests that customers cease use of all StrataMR valves and shunts that remain in inventory and return all unused units to Medtronic. If any StrataMR valves have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
Online: Complete and submit the report
Regular Mail or Fax: Download form or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178.
For further information or to report a problem, please contact Medtronic via phone at +1-800-335-9557 between the hours of 8am and 6pm (EST) or via e-mail at RS.MNSFCA@Medtronic.com.
The Medtronic StrataMRTM valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.
StrataMRTM valves are designed to withstand unintended changes in performance level settings due to external magnetic influences, including magnetic resonance imaging (MRI) up to 3.0 Tesla, when scanned in accordance with the MR conditions in the labeling.
StrataMR Adjustable Pressure Valve
View the features and mechanism of the StrataMR valve.
Confidently and non-invasively adjust and confirm the valve’s performance level without the need for radiographic confirmation. StrataMR™ adjustment tools are the only tools you can use to adjust StrataMR™ valves.
Three tools come packaged in a nonsterile, reusable case. You need all three to set or change the pressure/performance level setting of StrataMR™ valves.
When using the adjustment tool, you must first lift up the valve mechanism and then turn it to change the valve performance level setting.
The StrataMR™ adjustment tools are MR unsafe. Do not take the adjustment tools or the case into an MRI facility, as these magnets could potentially be a safety hazard to patients and users.
StrataMR Adjustable Pressure Valve Instructions for Use
Find this technical manual in the product labeling supplied with each device or call Medtronic at 800-961-9055.
StrataMR Quick Start Adjustment Guide
This technical guide shows how to use the StrataMR adjustment tools to pre and post-operatively adjust StrataMR valves.