A physician reported a certas valve (id 828806) was implanted via l-p shunt on unknown date with unknown settings.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Due to suspicion of obstruction, the valve was removed and replaced on (b)(6) 2022.
|
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10 the certas valve (id (b)(6) was not returned for evaluation (as per customer, product not available) and 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 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.
|