It was reported that a progav 2.0 shuntsystem (#fx643t) was implanted during a procedure.According to the complainant, , the shunt system caused an underdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 1 year, 5 months.Height: 68 cm.Weight: 10.8 kg.Gender: male.
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Investigation: visual inspection: during the investigation, deposits on the device were 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 operate within the permissible tolerance in their respective relevant positions.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valves, deposits were found in both valves.Results : in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we can determine adjustment difficulties in the valve.The determined deposits can be named as the cause for the adjustment difficulties.Organic material 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.
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