The returned valve was patent.The valve met the requirements for siphon, reflux, and leak testing.However it did not meet the requirements for pressure flow and preimplantation testing.Proteinaceous debris was observed in the interior and on the exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ all valves are 100% tested at the time of manufacture.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part a good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient had persistent low-pressure headache symptoms consistent with overdrainage.It was stated the valve was tested on the back table after explant, and it slowed to 10-11cm pressure and continued to slowly drain.The proximal and distal catheters were working well.Following the explant, the patient was doing good.
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