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

Model Number 9736242

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.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 that the navigation system would not boot.It was reported that the system would be unresponsive while booting and an error message displayed indicating the system would attempt to restart.There was no patient present when this issue was identified.

Manufacturer Narrative

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.

Event Description

Additional information was received stating that the problem came while booting the system.The hardware was checked but nothing was found.

Manufacturer Narrative

H3: a software analysis was initiated.However, it was found that there was insufficient information to determine the relationship of the software to the reported issue.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: STEALTHSTATION FLEXENT
• 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: 10861120
• MDR Text Key: 216949463
• Report Number: 1723170-2020-03025
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• PMA/PMN Number: K200723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

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: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 03/22/2021; 06/15/2021
• Supplement Dates FDA Received: 03/22/2021; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1