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Model Number 46128 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Unable to provide healthcare professional information due to privacy regulations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information regarding an external drainage and monitoring system.It was reported that during normal usage and routine nurse checks on the patient, it was realized that the tubing connecting to the chamber was loose, and cerebrospinal fluid (csf) was leaking out from the faulty area.The device was replaced with a new one.The patient's status at the time of the report was alive-no injury.
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Search Alerts/Recalls
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