MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number UNKNOWN-S |
Device Problems
Mechanics Altered (2984); Insufficient Information (3190)
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Patient Problems
Vomiting (2144); Dizziness (2194); No Code Available (3191)
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Event Date 09/18/2020 |
Event Type
malfunction
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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 the patient was implanted with a pressure regulator on (b)(6) 2019 due to hydrocephalus.On (b)(6) 2020, the patient had symptoms of vomiting, dizziness, and loss of appetite.The patient was currently at home, and still had symptoms of vomiting, dizziness, and loss of appetite.
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Event Description
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Additional information received reported that according to the patient's mother, the patient went to kindergarten, and it was highly suspected that the magnetic door curtain of kindergarten might have caused the valve pressure to change causing the patient to have symptoms.When the pressure was measured, the valve performance level jumped between 1.0 and 0.5.A pressure adjustment was completed on (b)(6) 2020 where the valve was set to 2.5 according to the requirements of the patient's mother and doctor advice.
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