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

Model Number	S7
Medical Device Problem Codes	Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.The representative reported that they were able to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The logs for the navigation system were evaluated by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.
Event or Problem Description
A site representative reported that, while manipulating exams in the cranial application software, the navigation system became unresponsive.A hard restart of the navigation system resolved the reported issue.No additional information was provided.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
The software investigation found that the reported event was related to a software issues.The issues were documented in a medtronic navigation software anomaly tracking database.

• 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: 6508370
• Report Number: 1723170-2017-01734
• Device Sequence Number: 1457598
• 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): 05/26/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1