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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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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 Key18999105
MDR Text Key338910025
Report Number1723170-2024-00944
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00763000359881
UDI-Public00763000359881
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/28/2024
Date Device Manufactured12/03/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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