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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 Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/21/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative inspected the navigation system on-site. When this issue was happening frequently, the representative uninstalled the application including shared resources completely. When reloading the software, the representative was getting an error message stating that the system was unable to install. It kept failing to install each time; that is when the computer was replaced. The issue was resolved with computer replacement. The malfunctioning computer has not been received by the manufacturer for evaluation. A full navigation system check-out was completed and all tests passed. Full system functionality was confirmed and the system was returned to service.
 
Event Description
A medtronic representative reported that the navigation system was becoming unresponsive intermittently. The user attempted to uninstall and then reinstall the software, but the software was unable to complete the install. There was no patient present when this issue was identified. No additional details were provided.
 
Manufacturer Narrative
The software investigation 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
826 coal creek circle
louisville, CO 80027
7208902439
MDR Report Key6182714
MDR Text Key62718731
Report Number1723170-2016-05839
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K050438
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
Report Date 03/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model NumberS7
Device Catalogue Number9733858
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 Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2016
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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