Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the valves operates within the accepted tolerance in the horizontal positions.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the given specifications.Internal inspection: after dismantling of the valve, deposits were found in progav 2.0.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine deposits.The deposits had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
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It was reported that a prosa (#fv701t) was implanted during a procedure performed on unknown.According to the complainant, the shunt showed an over-drainage and adjustment problems.The patient underwent a revision procedure performed on unknown.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 13 years, weight: 68 kgs, height: 140 cm, gender: female, same event as # 3004721439-2023-00350.
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