MEDTRONIC NEUROSURGERY STRATA NSC VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number 42365 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Hemorrhage, Intraventricular (1892)
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Event Date 09/08/2020 |
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 on (b)(6) 2020, the patient was implanted with an adjustable pressure shunt due to hydrocephalus.On (b)(6) 2020, symptoms of intra-ventricular hemorrhage were found through ct examination.The surgeon adjusted the pressure gear to 2.5, and the symptoms were relieved.Then on (b)(6) 2020, an increase in cerebral effusion was found through ct review again, and the doctor informed that it was excessive drainage.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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Additional information received reported that it was unknown if there were any environmental / external / patient factors that may have led or contributed to the issue; however, they couldn't completely exclude the influence of external factors.The actions taken to resolve the excessive drainage was ligation of the infusion tube.
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Search Alerts/Recalls
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