MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733560XOM FUSION EM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560XOM

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: software, 9733467, fusion ent, app version (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding navigation system that was used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the site was having issues with inaccuracy when registering and verifying their patient.They were verifying on the tip of the nose but it was 3-4 mm anterior.The representative had spoken with the site over the phone, and was able to help troubleshoot.The site tried re tracing, and also tracing lightly on the skin.The site never followed up after this phone call, so it is unknown if troubleshooting resolved the issue.There was an unknown delay in the case.There was no patient impact related to the event.

Event Description

Additional information was received.There was a less than 1 hour delay to the procedure.The cause of the issue was determined to be the placement of the emitter compared to the patient head and the trackers.It was reported that the issue was resolved at the time of the event by troubleshooting through re-positioning the emitter and re-registering the patient.

Manufacturer Narrative

Patient information provided.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 functioned as designed.The system then passed the system checkout and was found to be fully functional.A software analysis was initiated as part of the investigation.Analysis found that the reported behavior was the intended functionality of the software.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: CART 9733560XOM FUSION EM SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9461247
• MDR Text Key: 188082725
• Report Number: 1723170-2019-05997
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2020

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: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 02/24/2020
• Supplement Dates FDA Received: 12/19/2019; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 86