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Model Number 44010 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.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 regarding a ventricular inlet being used in a hydrocephalus case.Due to hydrocephalus, the patient underwent a reservoir bag placement operation.A medtronic reservoir bag was used.Intraoperative drainage, fluid leaked, and then was replaced with the a new reservoir bag.The procedure was completed successfully.No impact to patient outcome.There were no environmental/external/patient factors that may have led or contributed to the issue.
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Manufacturer Narrative
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No signs of damage were observed on the port or catheter.Biological debris were observed on the top of the port and body of the catheter.Laboratory personnel could not replicate the failure observed in the field.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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Search Alerts/Recalls
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