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Model Number 46700 |
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 04/26/2024 |
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 3 days after implantation, leaking was discovered when using the device.The device was replaced with a new one.The patient's status at the time of the report was alive-no injury.The patient's medical history included skull fracture, brain contusion, hematoma, and cerebrospinal fluid leak.
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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.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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Search Alerts/Recalls
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