MEDTRONIC MEXICO EDM VENTRICULAR CATHETER, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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Model Number 26020 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding an external drainage and monitoring system catheter.It was reported that during the patient's confusion and when they got up, the drainage tube broke.After the doctor reviewed the ct scan, the condition was stable, and the drainage tube was pulled out.There was no adverse harm.
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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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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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