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

Model Number 9735602

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

H3, h6: no products have been received by the manufacturer for analysis.  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 device being used in an unknown procedure.It was reported that the site could not get the navigation system to register.The doctor was putting in a balloon once registered.Once registered, the navigation was off on the target. the machine would not register.After it finally registered, 20-30 min later the doctor said the image was off.The computed tomography (ct) input into the machine had the tip of the nose missing.There was less than an hour delay in surgery.There was no impact on patient outcome.

Manufacturer Narrative

D10: concomitant product; id: 9735736, version: 2.0.1.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: additional information added to b5.D1-4 updated as we received information this reported issue occurred with a fusion compact.Additionally, the concomitant product has also been updated to reflect the correct system software.Other relevant device(s) are: product id: 9735638, version: unknown, ubd: unknown, udi#: unknown as follow-up is still being done this event, the root cause of the reported issue is under investigation.Once follow-up has been completed, an additional report will be submitted.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.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

Additional information was received.It was reported that the scan was very limited with hardly any forehead, and the registration failed several times resulting in a delay of five to ten minutes.The emitter was not working due to having to change the usb port.It was necessary to restart the system that was indicated by the red x over the emitter.After that was corrected, there was the issue with the scan itself.The registration issue was resolved by raising the location of the patient tracker higher on the patient's forehead to get registration to pass.Originally, the tracker was placed very low, closer to between the eyes.Every time the doctor would trace in be in that area, the system would think the surgeon was trying to register an instrument rather than trace anatomy.Once the tracker was placed higher on the forehead even though the scan was cut off, registration occurred right away and was accurate.It was indicated that the issue was related to user error when it came to the patient tracker placement, and this specific system often experiences emitter issues.

Event Description

Additional information was received.It was reported that there was not an accuracy issue.The issue was that the system was unable to pass registration for three to four attempts.The procedure being performed was a functional endoscopic sinus surgery (fess.).

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.

Manufacturer Narrative

H2/h6: the software logs were analyzed.There was insufficient information to determine the cause of the issue.Codes b01, c19, and d15 apply.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 COMPACT
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17458187
• MDR Text Key: 320383578
• Report Number: 1723170-2023-01387
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Device Lot Number: -
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 10/11/2023; 10/16/2023; 11/09/2023
• Supplement Dates FDA Received: 09/19/2023; 10/11/2023; 10/19/2023; 11/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male