MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560XOM

Device Problem Output Problem (3005)

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

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that this issue occurred during multiple surgical procedures, but the patient/procedure information for each of the cases could not be obtained.Other relevant device(s) are: product id: 9731203, serial/lot #: unknown.A medtronic representative went to site and performed a system checkout.It was noticed that a loaner emitter improved tracking, so the emitter was replaced.The system then passed checkout.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during an unknown procedure.It was reported that the system has had intermittent tracking issues during clinical cases.While working with manufacturing representatives at the site, the issue was replicated.They isolated that from metal interference and slight movements of the trackers would cause large changes in the metal interference vale and the instruments would stop tracking.There was no reported patient impact correlated with these issues.

Manufacturer Narrative

Concomitant medical products: the lot number was updated: serial/lot #: (b)(6) analysis was done, and originally it was reported that the problem could not be duplicated.The field generator was connected to a test system for a burn-in test.The system remained in green status during all testing.Flexing the cable does not indicate any intermittent opens.Fully functional.However it was then updated to say that the reported problem was confirmed.Instrument would become unstable for a short period of time and would track normally most of the time.Failure would happen intermittently.H6) 10,120,4307 are associated with the product analysis on the instrument.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: 9693942
• MDR Text Key: 183792005
• Report Number: 1723170-2020-00435
• Device Sequence Number: 1
• Product Code: HAW
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1