MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id:9736113, version: 1.0.5 : logs have been returned and are currently under analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported when the manufacturer representative tried to pull logs in admin status, they received a phyton error.The representative tried to reboot the system, but received a message stating, "error attempting to write to lower page" that was repeating on the screen.The representative then did a hard reboot and when the system was booting up they received the ubuntu menu.Technical services walked the representative through the menu and they were able to log into admin.Once in admin, it was found that the time and date were incorrect, which the representative resolved.The representative was then able to pull the logs and open other applications within admin.The representative rebooted and successfully logged in as a user.It was noted that the system has been powered off and not in use since february.There was no patient involvement.

Manufacturer Narrative

H3: a software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.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.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10063187
• MDR Text Key: 191181405
• Report Number: 1723170-2020-01443
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

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: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1