Unique device identifier (udi)- (b)(4).The certas valve was not returned for evaluation(still implanted), therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for ¿settings moved¿ could be due to the fact that ¿physician thinks they changed the op and they haven't" that may occur for example if "helical spring fails to hold rc in a seated position".As specified in the ifu in warning section : "testing shows that the valve mechanism is resistant to unintended changes in the setting in a 3tesla mri.However, the clinician should confirm the valve setting after a magnetic resonance imaging (mri) procedure.The valve setting is adjusted with the application and manipulation of strong magnets.A change to the valve setting is unlikely to occur under normal circumstances.However, magnetic fields should not be placed near the valve due to the possibility of an unintentional setting change¿.
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