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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 09/21/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. The representative reported that the computer for the navigation system was replaced, but the reported issue was not resolved. It was reported that following replacement, a ¿no signal¿ message appeared on the navigation system when exiting the administrative portion of the software. It was noted that the navigation system was unresponsive for five minutes during this phase and a hard restart of the system was performed. A second medtronic representative reported that the video splitter was bypassed without resolution. It was reported that the navigation system would function as designed prior to the fan cover being placed on the navigation system near the computer. It was reported that the axiem communication cable was disconnected, the fan cover was placed back on and the reported issue of ¿no signal¿ messages being displayed could not be replicated after a restart of the system. The representative reported that the axiem communication cable was replaced to resolve the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The computer for the navigation system was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The communication cable was returned to the manufacturer for analysis. The cable was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Event Description
A medtronic representative reported that while outside of procedure, when entering admin after powering on the navigation system, the screen displayed black and became unresponsive. Representative hard shutdown the system and when booted back on, the camera lights were on but the computer fan was cycling and the screen displayed blank. After performing a hard shutdown again the system functioned normally. Representative was able to progress to admin desktop. There was no patient present at the time of the issue.
 
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Brand NameSTEALTHSTATION S7 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
prashanth gali
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6962328
MDR Text Key90646671
Report Number1723170-2017-04233
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2010
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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