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

Model Number	9734048
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.It was reported that the system shows "failure in srmanager".The hardware and instruments passed the system checkout.Further analysis pending.Report source: (b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system that was used outside of procedure.It was reported that the computer does not fully boot up.It stops on "loading kernel" there was no patient present.On 2020-jan-10 it was reported that the cause of the issue was that there were some corrupted files in operation system.The computer of the system will be replaced to resolve the issue.

• 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: 9612832
• Report Number: 1723170-2020-00201
• Device Sequence Number: 19502384
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 01/09/2020
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1