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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 Image Display Error/Artifact (1304); Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. No parts have been returned to the manufacturer for evaluation. Device manufacturing date is unavailable at the time of filing.
 
Event Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure. The issue occurred intraoperatively during the navigate task and caused no delay to the surgery. It was reported that the images were taken on the imaging system in the correct orientation, but when they were transferred to the navigation device, the images were flipped. The site was able to manipulate the images to get them in the correct orientation for the case. The surgery was completed with navigation and there was no impact on patient outcome.
 
Manufacturer Narrative
Additional information: manufacture date provided. A medtronic representative went to the site to test the equipment. Testing revealed that the issue could not be replicated. It was noted that the intended use of the navigation system by the site was not within specifications of the system. The system then passed the system checkout and was found to be fully functional.
 
Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue. Analysis found that the software functioned as designed.
 
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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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7702839
MDR Text Key114468886
Report Number1723170-2018-03587
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
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 Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2017
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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