MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733560XOM

Device Problem Human-Device Interface Problem (2949)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: field generator 9731203 em mobile.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used outside of procedure.It was reported that the emitter was not "sensing correctly" and the site was requesting a system checkout.There was no patient present.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess).It was reported that the emitter was not "sensing correctly" and the site was requesting a system checkout.There was a procedure delay of less than one hour and no patient impact.

Manufacturer Narrative

H6, the fdp code was updated.H3/h6: the system was serviced in the field.Although the behavior was unable to be replicated the site stated it was not registering or tracking properly.The system failed hardware tests.The emitter was replaced at request of the site and the failure was resolved and passed all tests.Codes 10, 4203 and 4307 are applicable.H3/h6: troubleshooting determined that the cause was due to the new monitor being too close to the field.Once it was moved, tracking was performing as intended.Codes 10, 213 and 67 are applicable to this.H3/h6: the emitter was returned and the reported problem could not be duplicated.The field generator was connected to a test system for a multi-day burn-in test.The system remained in green status during all testing.Flexing the cable does not indicate any intermittent opens.It was fully functional.Codes 10, 213 and 67 are applicable to this.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H2: correction - the fdp code has been corrected.H3: additional information was received.The lot number for the emitter is 0400006820.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that the emitter was not "sensing correctly" and the site was requesting a system checkout.There was a procedure delay of less than one hour no patient present.Troubleshooting was performed by a biomedical engineer.They checked through the eminterface with no faults visible.It was later reported that the site was using a new monitor too close to the field which was causing the issue.It was confirmed that when they pulled it away tracking was normal.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9632314
• MDR Text Key: 183793190
• Report Number: 1723170-2020-00242
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169518452
• UDI-Public: 00643169518452
• Combination Product (y/n): N
• PMA/PMN Number: K001284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1