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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735669
Device Problems No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 01/29/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative confirmed that the leds were not lighting up on uninterruptible power supply (ups) despite being properly connected on both ends. Representative reported that the reported issue was intermittent. A uninterruptible power supply (ups) was replaced and the issue resolved. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect uninterruptible power supply (ups) has been received by the manufacturer for evaluation. The returned uninterruptible power supply (ups) was tested and found to power on all ports when power button was pressed and all outputs measured expected voltages. Fets measure as designed. When attempting to check charging circuit, battery was attached and when power was applied, the red error light would flash. The issue could be reproduced with two other different known good batteries.
 
Event Description
A medtronic representative on behalf of site reported that while outside of procedure, when setting up for case after a successful case with the navigation, the monitor of the system displayed black. Rebooting the system multiple times did not resolve the issue as the system did not display medtronic logo. Site verified that all cables were seated and attempted to turn on the monitor with the buttons on the bottom right of the screen. No additional information was provided. There was no patient present at the time of the issue.
 
Manufacturer Narrative
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.
 
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Brand NameSTEALTHSTATION S8 EM ENT 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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7289122
MDR Text Key100769192
Report Number1723170-2018-00813
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735669
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2017
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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