The certas valve was not returned for evaluation 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 shunt infection.It was reported that the certas valve(8288xx) connected to a bactiseal (manuf report number 3013886523-2020-00294) was implanted via v-p shunt on unknown date with unknown setting.After a month, shunt infection was observed.The valve was replaced to a new one.It is unknown if the infection is device related.Additional information was requested in regards culture results and treatment; however, the information was not provided.
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