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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); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2018
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 when uninstalling some of the software the system became unresponsive and rebooted itself to main page. Representative then continued and successful unistalled the software. When trying to reinstall the software, the system became unresponsive again and the screen flickered. A hard reboot was performed and when tried to reinstall the same issue persisted. It was reported that keyboard and mouse were not responding or lighting up. A no signal was displayed but the cd could still be opened and closed. A computer was replaced to resolve the issue. The system then passed the system checkout and was found to be fully functional. The computer was returned to the manufacturer for analysis. Analysis found that no intermittent unresponsiveness was observed. Computer passed all tests and no errors were encountered. No fault found. The logs for the navigation system were reviewed by medtronic personnel. However, the logs provided no additional insight into the probable cause of the anomaly.
 
Event Description
Medtronic received information regarding a navigation system outside of a procedure. There was no patient present. It was reported that when booting up the system it became unresponsive multiple times. This happened once the system arrived at the application launch screen and at the "select surgeon" screen.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through known anomaly determination. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.
 
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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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7621615
MDR Text Key111843866
Report Number1723170-2018-02899
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2012
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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