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

Model Number	9734060
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative went to the site to test the equipment.Testing revealed that the original issue was a red error led on camera, broken fiber optic cables, and damaged transceiver.Those issues were repaired but there was no communication with the camera.Bypassed transceiver/fiber communication chain and the camera connection was restored.The camera then would constantly cycle and found that the firmware did not match.The representative updated the firmware of both camera and polaris spectra system control unit (scu) and then, the imaging system then passed the system checkout and was found to be fully functional.Analysis on the returned transceiver resulted in a physical damage failure being found through functional testing and visual/physical examination.Analysis states that there was damage to the network and usb fiber ports.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 outside of procedure.It was reported that the camera was cycling.The ndi toolbox configuration was showing that the firmware was incompatible.The representative replaced the transceiver in the nui and was able to run the installer.The issue was then resolved.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8586566
• Report Number: 1723170-2019-02198
• Device Sequence Number: 1667415
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 05/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1