MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 42866 |
Device Problems
Inaccurate Flow Rate (1249); Mechanics Altered (2984)
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Patient Problems
Vomiting (2144); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)
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Event Date 10/31/2017 |
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 that prior to the implant of the shunt, the patient experienced syncope and was hospitalized in early (b)(6) 2012.A few days after the syncope, they underwent tumor resection with a suboccipital approach.The patient had a ventriculoatrial shunt installed by the end of (b)(6) 2012.A few years later, in late (b)(6) 2016, the patient¿s brain tumor recurred.They underwent tumor resection in early (b)(6) and the pressure level (pl) setting of the valve was set to 0.5.The patient experienced vomiting, unstable walking, and was unresponsive in (b)(6) 2017.The patient was admitted with the pl setting still at 0.5.It was stated that 200-300 ml of cerebrospinal fluid was drained from the patient and their symptoms improved.In late (b)(6) , the patient had exploratory surgery and after the operation was better, however would soon regress.It was noted the patient repeatedly had mris done following surgery and could not reach the same drainage effect as experienced prior to the mri.The doctor questioned whether the valve was damaged.The shunt was removed and replaced.
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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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Manufacturer Narrative
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The returned valve was patent.It met the requirements for siphon, and pre-implantation testing.The valve did not meet the requirements for reflux and pressure-flow testing.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open resulting in fluid reflux and affecting the flow of fluid through the valve.Instructions for use (ifu) 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.¿ the returned valve also did not meet the requirements for leak due to multiple tears in the top of the reservoir.It is unknown how or when this damage occurred.The ifu caution that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, or crushing of components.¿ the ifu also caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.All valves are 100% tested at the time of manufacture.Upon review of the analysis results, it was determined that eval code conclusion 92 no longer applies.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 was received from a health care provider (hcp) via a manufacturer representative (rep).It was confirmed that the valve settings were changed after the mri.
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Search Alerts/Recalls
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