MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC I7 INTEGRATED STEALTH STATION 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 medtronic representative went to the site to test the equipment.Testing revealed that the computer needed to be replaced.Once the computer was replaced, the system then passed the system checkout and was found to be fully functional.Analysis on the returned computer resulted in no failure being found.Analysis stated that the computer boots normally to the application screen.Seatools long test and memtest86 had no errors.The computer passed phd testing.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 intra/peri-operatively of a cranial resection procedure.It was reported that the system exited.They were navigating and part way through it exited to a boot text screen.The site confirmed that it eventually switched back to the register task without being touched.The site was able to proceed.There was a less than 1-hour delay to the procedure and no impact on patient outcome.
Additional Manufacturer Narrative
Patient information has been updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: I7 INTEGRATED STEALTH STATION NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8074666
• Report Number: 1723170-2018-05672
• Device Sequence Number: 2364422
• Product Code: HAW
• UDI-Device Identifier: 00613994665928
• UDI-Public: 00613994665928
• 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): 12/05/2018

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: Health Professional
• Device Model Number: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 75