MEDTRONIC MEXICO EXACTA DRAINAGE SYSTEM, 100ML; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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Model Number 46705 |
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 03/26/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding an external drainage and monitoring system.It was reported that on (b)(6) 2024, after the connection during the surgery, leakage was found at the tee-joint.
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Manufacturer Narrative
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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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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