Model Number FX648T |
Device Problems
Mechanical Problem (1384); Infusion or Flow Problem (2964)
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Patient Problem
Hydrocephalus (3272)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
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Event Description
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It was reported that a progav 2.0 was implanted during a procedure performed on unknown.According to the complainant, the valve showed adjustment difficulties.The patient underwent a revision procedure performed on unknown.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
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Manufacturer Narrative
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Investigation: visual inspection during the investigation, no significant deformations or damage of the valve were determined.Permeability test: a permeability test has shown that all components are permeable.The drained liquid was clear.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 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: based on our investigation results, we can determine adjustment difficulties in the progav 2.0 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.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 (#fx648t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in overdrainage and 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: 4 years, 8 months.Height: unknown.Weight: 30 kg.Gender: male.
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Search Alerts/Recalls
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