MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the equipment.It was reported that the computer was replaced.The hard are, software, and instruments passed the system checkout.The system was found to be fully functional.The computer was under analysis on the date of filing, therefore no results were available.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 that during the navigate task of a cranial biopsy procedure, the system was on the register screen and was unresponsive.They rebooted and were able to proceed with the case, however part way through the case the system exited to a black boot text screen and became unresponsive.After 10 minutes they hard booted the system and were able to complete the case.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
After reviewing the case and the system logs, the software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville,co
• MDR Report Key: 8079526
• Report Number: 1723170-2018-05694
• Device Sequence Number: 19207706
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 80