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

Model Number 9735665

Device Problem Computer Software Problem (1112)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field the ssd was upgraded.The system passed all tests and was performing as intended.Codes (b)(4) are applicable.The ssd was received for analysis and the failure was confirmed.It was not possible to log in to the system.After entering the password, the software would act as if it was logging in, the black medtronic logo would appear, then the user would be kicked back out to the log in screen.It was noted that it was possible to log in to a different application.Codes (b)(4) are applicable.Not able to log in to stealth.After entering pw, software acts as if it is logging in; black medtronic logo screen appears and then kicks back out to the log in screen.Able to successfully log into stealthadmin though.Uploaded logs (b)(4) - unexpected exit/software unresponsive; other relevant device(s) are: product id: 9736411, serial/lot #: (b)(4), ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the manufacturing representative (rep) was unable to log in after completing the (b)(4) data migration utility and app install.The rep tried reinstalling (b)(4) without resolution.Technical services (ts) had the rep try reinstalling (b)(4) via disk.This did not resolve the issue.There was no patient present when this issue occurred.The representative later received a (b)(4) solid state drive (ssd) in a (b)(4) ssd box.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735737, software version: 1.3.2 h3, h6: the software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.Codes b01, c10 and d02 are applicable.H2: correction - see below.Please disregard the following statement that was included in h10 of the initial mdr.The analysis was properly summarized prior to this statement, however this statement was incorrectly left in h10."not able to log in to stealth.After entering pw, software acts as if it is logging in; black medtronic logo screen appears and then kicks back out to the log in screen.Able to successfully log into stealthadmin though.Uploaded logs afc: nafc0209 - unexpected exit/software unresponsive;" 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 S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12555388
• MDR Text Key: 274095193
• Report Number: 1723170-2021-02398
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."