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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
Catalog Number 9735665
Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 07/19/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No parts have been returned to the manufacturer for analysis.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the camera cart was not communicating. The system worked fine during a case in the morning. The manufacturer representative (mr) was using the system for another case and he powered on the navigation device and loaded up exams. He exited out of the software by going to the main login screen on the top right and selecting shutdown, the main cart monitor displayed no video detected, the blue light stayed powered on and he didn't hear the computer fan running, the main cart never shutdown fully. The camera cart monitor and camera cart power were still on but searching for connection at that point. The mr restarted everything, and the main cart monitor still showed no video, but the blue power light was on, the camera cart monitor showed unable to connect. He restarted again, and the main cart monitor came up correctly, but the camera cart connection was never established. The camera cart was displaying this indefinitely. The self-test showed main cart ups and camera cart ups connection was lost. There was no patient present when this issue was identified.
 
Manufacturer Narrative
A medtronic representative when to the site to test the navigation system. The router was replaced. A full system checkout was completed and the system performed as intended. If information is provided in the future, a supplemental report will be issued.
 
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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
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7781936
MDR Text Key117153708
Report Number1723170-2018-04028
Device Sequence Number1
Product Code HAW
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
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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