Model Number 9735665 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Event Description
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Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the camera was intermittently starting. there was no patient involvement.
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Manufacturer Narrative
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Continuation of d10: product id 9735670 (serial: (b)(6)); product type: ; implant date n/a; explant date n/a camera 9735821 vega base s8 svc h3) onsite functional and visual examination was performed by a manufacturer representative.The system passed a system checkout and was determined to be operational.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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Event Description
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Additional information was received.The cause of the issue was unknown.
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Search Alerts/Recalls
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