MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S8 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9735670
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.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 device being used for a cranial resection procedure.It was reported that the surgeon was satisfied with the registration, but during the surgery and navigating to known landmarks the surgeon felt inaccurate.The surgeon felt about 20 mm inaccurate superficially.There was no impact on the patient's outcome.A representative went on site and performed registration with a resin head using touch and trace.Both were successful in being accurate.1 patient had point merge with all fiducials in a circle on the back of the head.2 green points, 2 red points, and 4 yellow points.
Additional Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the logs and archives provided were insufficient information to determine a root cause of the reported behavior.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVIGATION STEALTH STATION S8 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9008687
• Report Number: 1723170-2019-04861
• Device Sequence Number: 2450143
• Product Code: HAW
• UDI-Device Identifier: 00643169722194
• UDI-Public: 00643169722194
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 9735670
• Device Catalogue Number: 9735670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 82