Model Number FX433T |
Device Problems
Mechanical Problem (1384); Infusion or Flow Problem (2964)
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Patient Problem
Hydrocephalus (3272)
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Event Date 10/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported that a progav 2.0 shuntsystem (#fx433t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system could not be adjusted.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.No patient data submitted and the release for investigation is still pending.
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Manufacturer Narrative
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Manufacturing site evaluation: 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 over- 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 both positions.Adjustment test: the progav 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 is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.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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Event Description
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It was reported that a progav 2.0 shuntsystem (#fx433t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system could not be adjusted and showed an over-drainage.The patient underwent a revision procedure on (b)(6) 2023.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 73 years.Weight: 57 kgs.Height: 171.4 cm.Gender: male.
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Search Alerts/Recalls
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