The certas valve (id unknown) was not returned for evaluation (as per customer, product not available).Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the programing issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.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 (id unknown) was implanted via unknown shunt on an unknown date with unknown setting.The valve was damaged and on (b)(6) 2022, the valve was removed and replaced.Based on information provided, it is unknown if the patient experienced any signs and symptoms due to valve damaged.
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