The 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.The possible root causes for "unable to set desired setting" could be due to "biosubstances interfering with programming mechanism" and/or multiple other factors such as patient's condition.-as specified in the ifu, "adverse events" section: "devices for shunting csf may have to be replaced at any time due to medical reasons or failure of the device.Keep patients with implanted shunt systems under close observation for symptoms of shunt failure.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway [.].Accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting".
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