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

Model Number	9733856R
Medical Device Problem Codes	Mechanical Problem (1384); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the system was running slow due to backed up exams.The old exams were deleted from the archive.The system then passed the system checkout and was found to be fully functional.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 the system was moving very slow and then became unresponsive on the blue screen.A soft reboot was completed, but the system was still slow.It was noted the patient screen was showing over 70% full.Technical services (ts) recommended deleting patients and checking/deleting old versions of software.This issue was noted outside of a procedure, and there was no patient involvement.

• Brand Name: STEALTHSTATION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8202906
• Report Number: 1723170-2018-06490
• Device Sequence Number: 1710460
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: 11/30/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1