MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problems No Display/Image (1183); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative reported that an ssd was replaced and the issue resolved.The suspect ssd has been received by the manufacturer for evaluation.The ssd was tested and found inconsistent boot patterns.Ssd would not boot successfully every time to the login screen.An error was found in the syslog.When the system was ran in software for over 24 hours, it did not exhibit any image issues.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that while outside of procedure, the monitor of the navigation system would intermittently display black.It was reported that rebooting the system resolved the issue sometimes however this time the screen did not come back on after multiple reboots.Medtronic home screen would be displayed but nothing appears after home screen.Verifying the connections and computer but the issue persisted.When the hdmi cable was plugged into camera cart monitor, there would be no image on the new monitor.Issue still persisted when the input was switched to hdmi on to monitor.There was no patient present at the time of the issue.

Manufacturer Narrative

Additional information: system checkout information.A medtronic representative went to the site to test the equipment.Testing revealed that after rebooting the system, the splash screen appears, but nothing appears after the splash screen.The ssd card was replaced.The system then passed the system checkout and was found to be fully functional.

Event Description

2018-(b)(6) 00633716 (rep): medtronic received information regarding a navigation device being used outside of procedure, with no patient present.It was reported that the site monitor was functioning normally and intermittently turns completely black.This was noted by the manufacture representative (rep) to have happened before and that rebooting the system resolved the issue in the past.This time, the screen would not come up after several reboots--the splash screen with the medtronic logo comes on, but nothing appears after that, including the "no input detected" message.The rep present verified that the connections to the monitor and computer with no resolution.It was further reported that when the rep tried plugging the hdmi cable into the camera cart monitor, were still would be no image on the new monitor either.It was noted that the issue occurred when the site was prepping for a demo.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735699, software version: 1.0.2, ubd: unknown, udi#: unknown h3: a software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.H6: fdm b01, fdr c10, and fdc d02 are applicable to the software analysis.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 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7327211
• MDR Text Key: 102017172
• Report Number: 1723170-2018-01073
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1