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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 Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: a medtronic representative reported that restarting the navigation system resolved the reported issue, and the site completed the procedure with the navigation system.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through log analysis. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The representative reported that the spinal application software was uninstalled and re-installed onto the navigation system. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A site representative reported that, while in a spinal fusion, the navigation system became unresponsive after a 3d image acquisition was transferred from the medtronic imaging system. It was reported that the issue occurred when a pointer was brought into the surgical field. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no impact on patient outcome. No additional information was provided.
 
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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
MDR Report Key7103349
MDR Text Key103033566
Report Number1723170-2017-05071
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2010
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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