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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 Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2016
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The reported event could not be duplicated by medtronic personnel.
 
Event Description
A medtronic representative reported that during a functional endoscopic sinus surgery (fess) the navigation system became unresponsive to any clicks or commands after the patient was successfully registered. The site was able to exit and shut down the system and reboot to resolve the issue. The surgeon completed the procedure with the use of the navigation system. There was no impact on patient outcome.
 
Manufacturer Narrative
The system logs were reviewed but provided no additional insight regarding the cause of the reported complaint. Two core. Reconstruct files were generated in one of the sessions, but one was truncated and the back trace of the other could not be obtained. 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
7208902338
MDR Report Key6143160
MDR Text Key61403485
Report Number1723170-2016-05333
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2016
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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