MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 AXIEM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	S7
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative reported that the computer for the navigation system was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has been received by the manufacturer for evaluation.However, results are not available at this time.
Event or Problem Description
A site representative reported that, while in a functional endoscopic sinus surgery (fess), the monitor on the navigation system flickered during navigation.Restarting the navigation system resolved the reported issue.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
The analysis on the suspect computer for the navigation system was completed by medtronic personnel.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: STEALTHSTATION S7 AXIEM SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6545469
• Report Number: 1723170-2017-01956
• Device Sequence Number: 13736761
• Product Code: HAW
• UDI-Device Identifier: 00643169105232
• UDI-Public: 00643169105232
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1