MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735669

Device Problem Human-Device Interface Problem (2949)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess).It was reported that while performing a fess case, the site was unable to complete a successful registration.The site reported that the points appeared to be far off the skin.There was a surgical delay of longer than one hour.There was no patient impact reported.The use of medtronic navigation was aborted.The following troubleshooting was performed: using the patient reference frame method of registration orientation, there was reportedly a large gap between the patient tracker and the skin of the 3d model.They attempted to shift the tracker closer to the skin, but was unsuccessful.They switched to tracer method of registration orientation, the collected trace points were still visibly off the skin on the 3d model.The patient tracker was displaying green in tracking view, but the registration probe was flickering red and green.The site confirmed use of registration probe and flat emitter, it was noted that the patient was large.They brought probe towards the emitter and the probe displayed solid green.They switched to 3-point touch with no effect.They switched to touch registration with no effect -- all points were red, when attempting registration again the system would only collect the 4th point.The skin of 3d model looks smooth, the entire nose is in view, though the top and back of the head is missing.No gaps inside the model.They backed out of procedure, no effect.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: sfw kit 9735736 stealth s8 ent eu-sc.The system was serviced in the field and passed system checkout and functioned as intended.Codes b01, c19, and d14 apply.Codes b17, c20, and d15 apply to the concomitant product.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 there was no impact on the patient's outcome.

Manufacturer Narrative

H2:updates in b5 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 software analysis was initiated.However, it was found that there was insufficient information to determine the relationship of the software to the reported issue.2 session of application logs present of the issue date.Logs captured 47 successful registration on the issue date with error metric varied from 6.0 mm to 3.4 mm and 53 unsuccessful registration due to accuracy was more than 5 mm and also observed the trace points was covered vary less in unsuccessful attempts of registration.Archive had 6-ct exams, among them some were not optimal because of irregular slice spacing and missing slices.Other than ct exams there were 2-other exams with an error.The scans should include from the top of the mandible to the top of the head to allow for more anatomy to register on, as the model was chopped from the top and back.Multiple registration was done and observed lot of points in the soft area and under the skin.Many points were overlapping each other and the trace pattern was not good.Logs and archive didn't capture the root cau se of the reported behavior.There was insufficient information to determine whether a software anomaly contributed to the reported behavior.H6: b01, c19 and d15 apply to the software 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.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL 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: 16412000
• MDR Text Key: 310249256
• Report Number: 1723170-2023-00252
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• 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
• Report Date: 04/28/2023

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: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 03/30/2023
• Supplement Dates FDA Received: 03/01/2023; 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 103 KG