MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION(TM) S7(R); INSTRUMENT, STEREOTAXIC

Model Number	9734048
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of casepart-257474 determined that there was insufficient information.Analysis of casepart-258013 determined an unexpected exit/software was unresponsive.The computer boots normally to the application screen.After launching the dicom q/r program the medtronic / dicom q/r logo started then the system froze at a blue screen.Memtest86-no errors.Seatools long test-no errors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the monitor picture showed a blue screen instead of the exam information which is normally showed within the trajectory views or coronal, axial, sagittal views.

• Brand Name: STEALTHSTATION(TM) S7(R)
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8431053
• Report Number: 1723170-2019-01188
• Device Sequence Number: 1019154
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/18/2019

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: Health Professional
• Device Model Number: 9734048
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1