MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Model Number UNKNOWN-S |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544); Cognitive Changes (2551); No Code Available (3191)
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Event Date 06/20/2019 |
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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Medtronic received information that patient began to suffer from poor mental condition, loss of appetite, and difficulty in moving.It was reported that the patient is implanted with medtronic's external pressure regulator due to hydrocephalus over 13 months ago.One year later, the patient began to suffer from poor mental condition, loss of appetite, and difficulty in moving.Ct examination shows that the cerebrospinal fluid increased, it is recommended that the patient adjust the pressure at present, the patient is at home with mental disorders, loss of appetite, and symptoms of difficulty in action.
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Event Description
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Additional information received reported that due to the changes in the patient's condition, the previously set pressure position was not suitable, and the drainage was insufficient, resulting in the appearance of clinical symptoms such as excessive ventricle.After the doctor made a clinical judgement, they notified the manufacturer representative to carry out the pressure regulation.At present, the patient did not show any symptoms of discomfort.The doctor suggested that the patient should be reviewed after 2 weeks.
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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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