It was reported to aesculap inc.That a progav 2.0 (#fx490t) was implanted during a procedure performed in 2010.According to the complainant according to the complainant, the shunt system has never been adjusted since it´s initial implant.When it was to be adjusted, it was not possible to change the valves settings.A revision has been scheduled for (b)(6) 2024.The complainant device will be returned to the manufacturer for evaluation.At the time of the creation of this submission, no patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).
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Corrected information: a2 patient age brand name d4 additional device information d9 device returned to manufacturer yes, date returned to manfucturer.Additional information: a3a patient sex a4 patient weight b7 relevant history d4 additional device information f9 apprixmate age of the device.Investigation: visual inspection: during the investigation, no significant deformation or damage of the shuntsystem were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: the opening pressure is measured by using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves were 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 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.
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