The certas valve was not returned for evaluation (as per customer, product not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.
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A physician reported a certas valve was implanted to a patient via v-p shunt early (b)(6) 2021 with setting 4.On (b)(6) 2021, the symptoms worsened and intracranial pressure increased and the setting was changed to setting 2; however, the flow below the valve could not be confirmed, and a contrast medium confirmed retention.The valve was replaced on (b)(6) 2021.
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