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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameSTEALTHSTATION S8 PREMIUM SYSTEM
Type of DeviceNEUROLOGICAL 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 Key7327211
MDR Text Key102017172
Report Number1723170-2018-01073
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169722187
UDI-Public00643169722187
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 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
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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