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 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The unique identifier was not known at the time of the event.Concomitant medical products: other relevant device(s) are: product id: 9735638, version #: 1.0.1.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that after loading the ct data the 3d and 2d images were always have to be adjusted before the registration.This issue has been happening for the last 3 months.

Event Description

Additional information was received.It was reported that the issue would occur when the patient exams were transferred via network, where the '.Dicom_settings' file was in use.

Manufacturer Narrative

H2: additional information was received.B5 has been updated.H2: additional analysis information was provided.There are 3 anonymized patient exams provided by the rep, each labeled by year.Technical services (ts) imported each one onto the system without any changes to the.Dicom_settings file, and again with the following lines added to the.Dicom_settings file: max_ct_pixel_value 4095 truncate_negative_pixels true constant_ct_pixel_offset 1024 in all cases, the initial import without changes showed the images with poor contrast looking washed out, and the 3d model looked like a rough-surfaced block.After making the recommended changes, all of the exams imported solid white with a solid block for the 3d model.Additional troubleshooting in the.Dicom_settings file determined that if the max_ct_pixel_value was removed, the images would import as if no changes were made.Modifying the other two lines had no impact on the final outcome.Previous codes are still applicable.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.

Manufacturer Narrative

H3) the archive from the reported issue was returned to the manufacturer for evaluation.Review of the archive found that the software of the navigation system functioned as designed.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

H3: a medtronic representative went to the site to test the equipment.Testing revealed that the navigation system was found to be fully functional.The navigation system then passed the system checkout and was found to be fully functional.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
• MDR Report Key: 11096303
• MDR Text Key: 224415892
• Report Number: 1723170-2020-03435
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2021

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: 1940652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/18/2021; 03/10/2021; 06/15/2021
• Supplement Dates FDA Received: 03/09/2021; 03/16/2021; 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."