1 of 2 reports.Other mfg report number: 3013886523-2021-00111.A physician reported issues with 2 hakim valves on the same patient: the valve was placed in a (b)(6)-year-old patient admitted with a diagnosis of cerebellar proliferative angiopathy with an ic bleed, complaints of headaches, vomiting and neck pain with a gcs of 15/15.The codman programmable shunt was placed on (b)(6) 2020 (initially the pressure was set at 120).Later, the patient developed subdural hygroma due to over drainage.The pressure was increased with the programmer.A post setting x-ray was done to check the pressure readings, which repeatedly showed wrong readings after correcting the pressure many times.It was decided on (b)(6) to change the shunt and replace it with a new programmable shunt.After the successful placement of the 2nd codman programmable shunt the settings were not able to be changed to the desired value.The patient had repeated x-rays of the skull but it never showed the desired pressure in the new shunt system.
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Hakim valve was not returned for evaluation and lot number information has not 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 "showed wrong readings repeatedly after correcting the pressures many times" 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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