A physician reported that in 2004 a codman hakim programmable valve (medos prog infant valvesystem) was implanted to a now 19-year-old patient via v-p shunt for congenital hydrocephalus with a setting of 150mmh2o.There was no pressure change after that.The patient was being followed up at another hospital.About a month ago, it was reported that the patient had difficulty seeing the physician¿s eyes and a cognitive decline was noted.When the mri was taken, the ventricles were slightly enlarged.The patient was referred to another facility.A new examination revealed that the abdominal catheter was torn in the chest.The operator tried to change the pressure but was unsuccessful.The pressure could not be changed even with neodymium.There is a plan to explant the shunt; however, no confirmation has been received.
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Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The valve was returned for evaluation.Device history record (dhr) - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock failure analysis - the valve was visually inspected; a cut/tear was noted in the silicone housing distal end, as well as a crack in the valve casing, calcification was noted on outside of valve.The catheters were visually inspected and calcification was noted on 2 pieces of catheter.The position of the cam when valve was received was 170mmh2o.The valve was hydrated.The valve was leak tested and failed.A leaked from the cut/tear in the silicone housing distal end.The valve passed the test for programming, occlusion and pressure.The root cause for the issue reported by the customer, is due to the cut/tear in the silicone housing.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu: silicone has a low tear/cut resistance.The root cause for the crack in the valve casing is due to the valve receiving a hard knock.
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