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Model Number 9735602 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)
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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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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: product id 9735638 (software version 1.0.1); h3,h6) no parts have been received by the manufacturer for evaluation.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 a navigation system being used outside of a procedure.It was reported that the navigation did not work, there was an alleged inaccuracy.It registered, and then one side work when we went to do the other side it did not line up.It was way off. there was no patient involvement.
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Manufacturer Narrative
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H6) the system was serviced in the field and no faults were found, the system performed as intended.Codes b01, c19, and d14 are applicable.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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H2) additional information in section b5.H2) a-a4: patient information was unavailable from the site.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 received indicated the site was having intermittent issues with tracking and it was suspected that this issue was related to interference with metal in the room.Additional information received indicated the procedure being performed was a functional endoscopic sinus surgery (fess) in which there was there was no impact to patient to patient's outcome.The amount of inaccuracy was unknown and surgical delay was reported as 5-minutes.
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Search Alerts/Recalls
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