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

Model Number 9735602

Device Problem Connection Problem (2900)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that the system is unable to communicate with em components.The axiem box was previously replaced.The power cable was also recently replaced for a separate power issue.Troubleshooting included uninstalling/reinstalling 1.0 software.The em interface was then able to be opened.The drive and noise were noted to be okay.No fault codes were listed.The power supplies are noted to be okay.The system booted in the correct order.However, the software still displayed the emitter red x.Swapping the emitter and axiem did not resolve the issue.It is likely that the computer is the cause of the problem.There was no patient involvement.

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 (b)(6) then passed the system checkout and was found to be fully functional.Serial number (b)(6) lot # 2364263 was returned: the computer was not returned with any accessories.The computer powered up on the test bench without issue and had normal communication with the axiem and components.No problem found.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: 11024203
• MDR Text Key: 222069228
• Report Number: 1723170-2020-03305
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1