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

Model Number 9735665

Device Problems Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); Unexpected Shutdown (4019); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9736355 (software version: 2.0.3) multiple fdd/annex a codes were reported.A110201 was coded for the allegation the system was unable to boot up and that the system would not progress to the login screen.A0719 was coded for the allegation that the system tried to reboot itself.A1102 was coded for the allegation of the white text with green ok message when booting, red failed message when starting the pulse audio, no video detected message on camera, batt light on the ups was flashing orange, and error detected during startup message.H3, h6) no parts have been returned to the manufacturer for analysis.Applicable codes: b17, c20, d15.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding a navigation device.It was reported outside of a procedure that the system was unable to boot up.The ssd was replaced recently and the main cart monitor now went through a series of white text with green ok messages next to them when the system is turned on.It was noted that the camera cart displayed no video detected.A manufacturing representative (rep) confirmed that the system was plugged into its own power outlet and that there was only one ssd in the system.The led's were confirmed to be illuminated on the uninterruptible power supply (ups).The white text continued to run until it ran into a red failed message when starting the pulse audio.The batt light on the ups was flashing orange.The system was shut down and the main cart battery was disconnected from the ups and turned back on.The same white text displayed and eventually the system booted to the main login screen and the camera cart mirrored the main cart as expected.The system was shut down and the rep waited one minute before attempting to turn it back on.This time the system would not progress to the login screen.The system was shut down and all the cables from the computer and ups were disconnected except for the power cables to the ups, computer, monitor, and the video cable from the computer to the main cart monitor.An error detected during startup message appeared when the system was turned back on and then the system tried to reboot itself.All the cabling was reconnected while the system was off.The systemthen booted directly to the login screen with no white text when turned back on.The system was rebooted three more times and procedure setup was walked through with no issues.Resolution was confirmed on the call and there was no patient involvement.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18999105
• MDR Text Key: 338910025
• Report Number: 1723170-2024-00944
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000359881
• UDI-Public: 00763000359881
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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?: No
• Date Manufacturer Received: 03/26/2024
• Date Device Manufactured: 12/03/2021
• 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