MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 92856 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 11/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported the patient fell and hit their head in (b)(6) 2018.Following that, the patient¿s hydrocephalus symptoms deteriorated, and the patient visited the hospital.After checking the valve with a stratavarius, it was identified that the pressure setting was changed.It was confirmed that the stratavarius could adjust the valve to all settings.In addition, the shunt system¿s patency was identified by contrast.Both the valve and peritoneal catheter was replaced.The distal end of the catheter was occluded.The patency of the valve was confirmed, but analysis of the valve was still requested.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received reported the valve was implanted over two years prior.
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Manufacturer Narrative
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The returned valve was patent.It met the requirements for siphon, reflux, valve flux, pressure-flow and preimplantation testing.The valve setting did not change during the testing.The instructions for use states, ¿mri systems of up to 3.0 tesla may be used any time after implantation and will not damage the strata ii valve mechanism, but can change the performance level setting.The performance level setting should always be checked before and after mri exposure.¿ the valve did not pass leak testing due to multiple cuts near the inlet connector.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ there was proteinaceous debris observed on the interior and exterior of the valve.The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion¿¿ and ¿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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received reported that after replacing the valve and peritoneal catheter, the progress of the patient was good.It was stated that a foreign body was formed at the end of the peritoneal catheter so it was probably the cause of the occlusion.However, because the patient fell down and the valve was hit strongly, analysis on whether the valve was broken was requested.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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