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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); Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. It was reported that the monitor for the navigation system was replaced. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
A manufacturer representative reported that, while in a spinal fusion, the monitor on the camera cart of the navigation system lost display functionality. It was reported that restarting the navigation system did not restore functionality. The site opted to complete the procedure with the second monitor of the navigation system only. There was no reported delay to the procedure due to this issue. There was no reported impact on patient outcome. No additional information was provided.
 
Manufacturer Narrative
Additional information: device manufacture date the monitor was returned to the manufacturer for evaluation. After functional testing and visual/physical examination the reported issue was confirmed. When power was applied the state of the monitor did not change. The led indicator would not light. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a navigation hardware anomaly tracking database.
 
Manufacturer Narrative
Fda codes were updated to reflect current coding guidelines. 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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7360102
MDR Text Key103142355
Report Number1723170-2018-01219
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 company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2017
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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