MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: computer was returned, but analysis was not yet completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that the system was showing no input detected on boot up.They attempted to reboot a few times with the same result.No patient was present at the time of the event.
Additional Manufacturer Narrative
The computer was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The computer boots normally to the application screen.The computer booted multiple times during burn-in testing.No "no input" messages were observed.No error messages received.No failures found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8748404
• Report Number: 1723170-2019-03876
• Device Sequence Number: 2038437
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1