MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION 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 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9733467, serial/lot #: (b)(4).A medtronic representative went to the site to test the equipment.It was reported that no part of the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure.During the registration, a "scan was missing a substantial piece of the forehead." the was no metal interference when the emitter details were checked.The surgeon reportedly tried to register the patient 5 times unsuccessfully, and then moved forward without navigation.The manufacturer representative spoke with the surgeon about scan quality and requirements for the scan.The issue resulted in less than one hour procedure delay.There was no impact on patient outcome.2020-jan-14 additional information was reported.It was reported that no registration data was present since navigation was aborted.As mentioned, a substantial amount of the forehead was missing which likely contributed to registration issues.Unable to provide further feedback at this time without seeing the trace pattern the site done.Will follow up with the local team to train the site on proper imaging protocol and trace pattern.2020-jan-14 it was confirmed that the procedure was completed without navigation but imaging was not aborted.

Manufacturer Narrative

H3: software analysis determined that could not conclude the cause of the reported registration issues with the information provided.However, it was noted that a substantial portion of the patient's forehead was missing, which likely contributed to the registration issues.Technical services would follow-up with the site regarding proper imaging protocol and trace pattern.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: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9648868
• MDR Text Key: 178628266
• Report Number: 1723170-2020-00304
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 51 YR
• Patient Weight: 104