The hakim valve is still implanted and will not be returned for evaluation.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.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.
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A physician reported the valve was implanted in the patient via l-p shunt in 2015 with unknown setting.The valve was used with the silascon lumbar catheter (manufactured by (b)(4).The physician was able to change the pressure from 200 mmh2o to 60 mmh2o to 120 mmh2o, but could not change the pressure setting any more.The set pressure did not change from 200 mmh2o, and the physician tried to change the pressure several times with a neodymium magnet and a hakim programmer.The patient's condition is good.The patient is in the follow-up.
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