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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 Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 08/18/2018
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. Testing revealed that the monitor was unable to display video. The system main cart monitor was replaced. The system then passed the system checkout and was found to be fully functional. No parts have been returned to the manufacturer for analysis.
 
Event Description
Medtronic received information that, while outside a procedure, the camera and system cart monitors did not display video. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Additional information: report source - foreign.
 
Manufacturer Narrative
The monitor was returned to the manufacturer for analysis. Analysis found that the monitor was able to display video on both hdmi and dp modes. As well, audio worked on both inputs and the touch function worked, as intended. The monitor had quite a bit of debris between the screen and glass. 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
erika mitchellette
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7865308
MDR Text Key119931367
Report Number1723170-2018-04542
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
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 Manufacturer12/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2017
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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